Absorb IV Randomized Controlled Trial

A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 2610 subjects from approximately 140 sites in the United States and outside the United States. ABSORB IV is a continuation of ABSORB III (NCT01751906) trial which are maintained under one protocol because both trial designs are related. The data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.

The ABSORB IV Randomized Controlled Trial (RCT) is designed to continue to evaluate the safety and effectiveness as well as the potential short and long-term benefits of Abbott Vascular Absorb™ Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System (once commercially available), as compared to the commercially approved, control stent XIENCE.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Coronary Disease; Coronary Stenosis; Coronary Artery Stenosis
• Intervention / Treatment: Device: Absorb BVS; Device: XIENCE

Detailed Description

ABSORB IV:

A. Primary Objective:

• To evaluate 30-day clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.
• To evaluate long-term clinical outcomes of Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three denovo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.

B. Secondary Objectives:

• To evaluate 1-year clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.
• To evaluate the incidence of angina occurring within 1 year, with treatment of Absorb BVS compared to XIENCE.

The enrollment of the 2610 subjects in ABSORB IV will start after enrollment completion of the 2000 primary analysis subjects in ABSORB III. All registered subjects will have clinical follow-up at 30, 90, 180, 270 days and 1, 2, 3, 4 and 5 years.

Note: All registered subjects in ABSORB IV will be followed up to 5 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

In addition, all 2610 subjects in ABSORB IV will complete patient-reported outcome (PRO) self-administered questionnaires at baseline, 30 days,180 days, 1 year, 3 years and 5 years.

• Study Type: Interventional
• Enrollment (Actual): 2604
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital
  • Queensland
    • Brisbane, Queensland, Australia, 4032
      • The Prince Charles Hospital
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's Hospital Melbourne
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
    • Perth, Western Australia, Australia, 6001
      • Royal Perth Hospital
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Hopital du Sacre-Coeur de Montreal
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute
    • Montréal, Quebec, Canada
      • CHUM-Hotel Dieu
• Germany
  • Baden-Württemberg
    • Freiburg, Baden-Württemberg, Germany, 79106
      • Universitatsklinikum Freiburg
    • Ulm, Baden-Württemberg, Germany, 89081
      • Universitatsklinikum Ulm
  • Bavaria
    • Immenstadt, Bavaria, Germany, 87509
      • Kliniken Oberallgau gGmbH
    • Kempten-Allgau, Bavaria, Germany, 87439
      • Klinikum Kempten, Klinikverbund Kempten-Oberallgaeu gGmbH
  • Berlin
    • Bernau, Berlin, Germany, 16321
      • Immanuel Klinikum Bernau Herzzentrum Brandenburg
  • Hesse
    • Giessen, Hesse, Germany, 35392
      • University Giessen
  • Lower Saxony
    • Oldenburg, Lower Saxony, Germany, 26133
      • Klinikum Oldenburg
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany, 53105
      • Universitätsklinikum Bonn
    • Essen, North Rhine-Westphalia, Germany, 45138
      • Elisabeth-Krankenhaus
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Johannes Gutenberg-Universitaet
  • Schleswig-Holstein
    • Bad Segeberg, Schleswig-Holstein, Germany, 23795
      • Segeberger Kliniken GmbH - Herzzentrum
• Singapore
  • Singapore, Singapore, 169609
    • National Heart Centre, Singapore, Pte, Ltd.
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Chandler Regional Medical Center
    • Gilbert, Arizona, United States, 85297
      • Mercy Gilbert Medical Center
    • Scottsdale, Arizona, United States, 85258
      • Scottsdale Healthcare
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • California
    • Concord, California, United States, 94520
      • John Muir Health Concord
    • Fremont, California, United States, 94538
      • Washington Hospital
    • La Jolla, California, United States, 92037
      • Scripps Memorial Hospital La Jolla
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Sacramento, California, United States, 95817
      • Univ Of California Davis Med Ctr
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
    • Stanford, California, United States, 94305
      • Stanford Hospital and Clinics
    • Torrance, California, United States, 90503
      • Little Company of Mary Hospital
  • Colorado
    • Loveland, Colorado, United States, 80538
      • Medical Center of the Rockies
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Hospital
  • Florida
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital
    • Jacksonville, Florida, United States, 32207
      • Baptist Medical Center Jacksonville
    • Jacksonville, Florida, United States, 32209
      • UF Health Jacksonville
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
    • Springfield, Illinois, United States, 62769
      • St. John's Hospital
  • Indiana
    • Elkhart, Indiana, United States, 46514
      • Elkhart General Hospital
    • Indianapolis, Indiana, United States, 46237
      • Franciscan St Francis Health
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky Hospital
    • Louisville, Kentucky, United States, 40202
      • Jewish Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Maine
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • MedStar Union Memorial Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48197
      • St. Joseph Mercy Hospital
    • Detroit, Michigan, United States, 48201
      • Harper University Hospital
    • Detroit, Michigan, United States, 48236
      • St John Hospital & Medical Center
    • Petoskey, Michigan, United States, 49770
      • Northern Michigan Hospital
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Boone Hospital Center/ Missouri Cardiovascular Specialists, LLP
    • Saint Louis, Missouri, United States, 63110
      • Barnes Jewish Hospital
    • Springfield, Missouri, United States, 65804
      • Mercy Hospital Springfield
  • Montana
    • Missoula, Montana, United States, 59802
      • St. Patrick Hospital
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Nebraska Heart Institute Heart Hosp.
    • Omaha, Nebraska, United States, 68124
      • CHI Health Bergan Mercy
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
    • Camden, New Jersey, United States, 08103
      • Our Lady of Lourdes Medical Center
    • Englewood, New Jersey, United States, 07631
      • Englewood Hospital and Medical Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Flushing, New York, United States, 11355
      • NewYork-Presbyterian/Queens
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • New York, New York, United States, 10021
      • NYP Weill Cornell Medical Center
    • Rochester, New York, United States, 14621
      • Rochester General Hospital
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center
    • Syracuse, New York, United States, 13203
      • St. Joseph's Hospital Health Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center-Northeast
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Heart & Vascular Institute/Presbyterian Hospital
    • Charlotte, North Carolina, United States, 28210
      • Carolinas Medical Center-Pineville
    • Raleigh, North Carolina, United States, 27607
      • Rex Hospital, Inc.
    • Raleigh, North Carolina, United States, 27610
      • WakeMed
    • Winston-Salem, North Carolina, United States, 27103
      • Wake Forest Baptist Medical Center
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Hospital
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
    • Toledo, Ohio, United States, 43608
      • Mercy St. Vincent Medical Center
    • Zanesville, Ohio, United States, 43701
      • Genesis Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • INTEGRIS Baptist Medical Center, Inc.
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Holy Spirit Hospital
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Hospital
    • Harrisburg, Pennsylvania, United States, 17105-8700
      • Pinnacle Health Hospitals
    • Monroeville, Pennsylvania, United States, 15146
      • Forbes Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Presbyterian
    • Reading, Pennsylvania, United States, 19605
      • St. Joseph Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • AnMed Health Medical Center
    • Columbia, South Carolina, United States, 29204
      • Providence Hospital
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Holston Valley Medical Center
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Amarillo, Texas, United States, 79106
      • Northwest Texas Healthcare System
    • Austin, Texas, United States, 78705
      • Seton Medical Center
    • Dallas, Texas, United States, 75226
      • Baylor Heart and Vascular Hospital
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Tyler, Texas, United States, 75701
      • East Texas Medical Center
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Carilion Roanoke Memorial Hospital
    • Winchester, Virginia, United States, 22601
      • Winchester Medical Center
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Reg Med Ctr Everett
    • Northwest, Washington, United States, 20010
      • Medstar Health Research Institute/ Medstar Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

General Inclusion Criteria:

1. Subject must be at least 18 years of age.
2. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.

3. Subject must have evidence of myocardial ischemia (e.g., silent ischemia, stable or unstable angina, non-ST-segment elevation MI (NSTEMI), OR recent ST-segment elevation MI (STEMI). Patients with stable coronary syndromes can be enrolled any time after symptom onset if eligibility criteria are otherwise met. Patients with acute coronary syndrome can be enrolled under the following conditions:

   1. Unstable angina or NSTEMI within 2 weeks of the index procedure.
   2. STEMI > 72 hours ≤ 2 weeks prior to the index procedure.

   Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class.

4. Subjects must be suitable for PCI. Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objective signs of ischemia as determined by one of the following: abnormal stress echocardiogram, nuclear scan, electrocardiogram (ECG), positron emission tomography (PET), magnetic resonance imaging (MRI), and/or fractional flow reserve (FFR).

   (Note: subject with silent ischemia must have a prior history of typical angina, angina-equivalent symptoms, or atypical angina within the past year to be included in the trial.)

5. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
6. Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential a pregnancy test must be performed with negative results known within 7 days prior to the index procedure per site standard.
7. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for at least 1 year following the index procedure.
8. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 5 years following the index procedure.

Angiographic Inclusion Criteria:

Treatment of up to three de novo lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel. If only a single lesion is to be treated, it must be a target lesion. Up to one non-target lesion can be treated. Non-target lesion treatment can occur only in a non-target vessel.

If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion for lesion (and stent) length determination and must be treated with a single study device.

1. Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed %DS of ≥50% and < 100%, with a thrombolysis in myocardial infarction (TIMI) flow of ≥ 1, and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve ≤0.80 AND/OR a positive stress test), or presentation with an acute coronary syndrome (unstable angina or NSTEMI within 2 weeks of index procedure, or STEMI >72 hours but ≤ 2 weeks prior to the index procedure).

1. Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.
2. Target lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.

Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class.

Note: To exclude enrollment of excessively small vessels, if the operator believes that based on visual angiographic assessments, the distal reference vessel diameter is ≤ 2.75 mm such that the plan is to implant a 2.5 mm device (stent or scaffold) in a target lesion, it is strongly recommended that either on-line QCA or intravascular imaging (ultrasound or optical coherence tomography) is used and demonstrates that the measured distal RVD for this target lesion is ≥ 2.50 mm (by at least one of these imaging modalities). This measurement may be performed before or after pre-dilatation, but before randomization. If the distal RVD measures <2.5 mm, that lesion IS NOT ELIGIBLE for randomization. Such a lesion may be treated as a non-target lesion.

General Exclusion Criteria:

1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or a P2Y12 receptor inhibitor is planned within 12 months after the procedure.
2. Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
3. Subject has known allergic reaction, hypersensitivity or contraindication to any of the following: aspirin; or clopidogrel and prasugrel and ticagrelor; or heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
4. Subject had an acute STEMI (appropriate clinical syndrome with ≥1 mm of ST-segment elevation in ≥2 contiguous leads) within 72 hours of the index procedure.

5. Subject has a cardiac arrhythmia identified at the time of screening for which at least one of the following criteria is met:

   1. Subject requires coumadin or any other agent for chronic oral anticoagulation.
   2. Subject is likely to become hemodynamically unstable due to their arrhythmia.
   3. Subject has poor survival prognosis due to their arrhythmia.
6. Subject has a left ventricular ejection fraction (LVEF) < 30% assessed by any quantitative method, including but not limited to echocardiography, MRI, multiple-gated acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc. LVEF may be obtained within 6 months prior to the procedure for subjects with stable CAD. For subjects presenting with acute coronary syndrome (ACS), LVEF must be assessed within 1 week of the index procedure and after ACS presentation, which may include contrast left ventriculography during the index procedure but prior to randomization in order to confirm the subject's eligibility.
7. Subject has undergone prior PCI within the target vessel during the last 12 months. Prior PCI within the non-target vessel or any peripheral intervention is acceptable if performed anytime >30 days before the index procedure, or between a minimum of 24 hours and 30 days before the index procedure if successful and uncomplicated.
8. Subject requires future staged PCI of any lesion other than a target lesion identified at the time of index procedure; or subject requires future peripheral vascular interventions < 30 days after the index procedure.
9. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
10. At the time of screening, the subject has a malignancy that is not in remission.
11. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
12. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
13. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban, edoxaban or any other related agent for any reason).
14. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
15. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
16. Subject has renal insufficiency as defined as an estimated glomerular filtration rate (GFR) < 30 ml/min/1.73m2 or dialysis at the time of screening.
17. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastrointestinal or significant urinary bleed within the past six months.
18. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g. aneurysm, arteriovenous malformation, etc.).
19. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the patient if radial access may be used.
20. Subject has a life expectancy <5 years for any non-cardiac or cardiac cause.
21. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of Patient Reported Outcome instruments.
22. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
23. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with a mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

Angiographic Exclusion Criteria:

All exclusion criteria apply to the target lesion(s) or target vessel(s).

1. Unsuccessful pre-dilatation, defined as the presence of one or more of the following (note: successful pre-dilatation of at least one target lesion is required prior to randomization):

   1. Residual %diameter stenosis (DS) after pre-dilatation is ≥ 40% (per visual estimation). Note: achieving a %DS ≤ 20% prior to randomization is strongly recommended.
   2. TIMI flow grade <3 (per visual estimation).
   3. Any angiographic complication (e.g. distal embolization, side branch closure).
   4. Any dissection NHLBI grade D-F.
   5. Any chest pain lasting > 5 minutes.
   6. Any ST-segment depression or elevation lasting > 5 minutes.
2. Lesion is located in left main or there is a ≥30% diameter stenosis in the left main (unless the left main lesion is a protected left main (i.e. a patent bypass graft to the LAD and/or LCX arteries is present), and there is no intention to treat the protected left main lesion).
3. Aorto-ostial right coronary artery (RCA) lesion (within 3 mm of the ostium).
4. Lesion located within 3 mm of the origin of the left anterior descending artery (LAD) or left circumflex artery (LCX).

5. Lesion involving a bifurcation with a:

   1. side branch ≥ 2 mm in diameter, or
   2. side branch with either an ostial or non-ostial lesion with diameter stenosis >50%, or
   3. side branch requiring dilatation

6. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or XIENCE stent:

   1. Extreme angulation (≥ 90°) proximal to or within the target lesion.
   2. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
   3. Moderate or heavy calcification proximal to or within the target lesion. If intravascular ultrasound (IVUS) used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.
7. Lesion or vessel involves a myocardial bridge.
8. Vessel has been previously treated with a stent and the target lesion is within 5 mm proximal or distal to a previously stented lesion.
9. Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Absorb BVS; Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System	Device: Absorb BVS; Scaffold diameters: 2.5, 3.0 and 3.5 mm; Scaffold lengths: 8, 12, 18, and 28 mm. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.; Once Absorb GT1™ BVS System is commercially available, it can also be used in the ABSORB IV trial. Scaffold diameters: 2.5, 3.0 and 3.5 mm of and scaffold lengths: 8, 12, 18, 23, and 28 mm.; The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Active Comparator: XIENCE; Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) and XIENCE ProX (outside of the US only)	Device: XIENCE; Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).; Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm. The 3.25 mm is only available for XIENCE Xpedition; Stent lengths: 8, 12, 15, 18, 23, and 28 mm; For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Target Lesion Failure (TLF)	Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TLF at 1-year, Non-inferiority Against the Control	One-sided p-value by using Farrington-Manning non-inferiority test will be used with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025.	1 year
Angina at 1-year, Non-inferiority Against the Control	Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC).; This analysis will exclude angina or angina equivalent symptoms that occurred following the index procedure through hospital discharge or 7 days, whichever occurs first.	1 year
Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis)	Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.	In-hospital (≤ 7days)
Number of Participants With Acute Success- Procedural Success (Subject Level Analysis)	Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).	In-hospital (≤ 7days)
Number of Death (Cardiac, Vascular, Non-cardiovascular)	Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	In-hospital (≤ 7 days post index procedure)
Number of Death (Cardiac, Vascular, Non-cardiovascular)	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	30 days
Number of Death (Cardiac, Vascular, Non-cardiovascular)	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	90 days
Number of Death (Cardiac, Vascular, Non-cardiovascular)	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	180 days
Number of Death (Cardiac, Vascular, Non-cardiovascular)	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	270 days
Number of Death (Cardiac, Vascular, Non-cardiovascular)	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	1 year
Number of Death (Cardiac, Vascular, Non-cardiovascular)	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	2 years
Number of Participants With Myocardial Infarction (MI)	Attributable to target vessel (TV-MI); Not attributable to target vessel (NTV-MI)	In-hospital (≤ 7 days post index procedure)
Number of Participants With Myocardial Infarction (MI)	Attributable to target vessel (TV-MI); Not attributable to target vessel (NTV-MI)	30 days
Number of Participants With Myocardial Infarction (MI)	Attributable to target vessel (TV-MI); Not attributable to target vessel (NTV-MI)	90 days
Number of Participants With Myocardial Infarction (MI)	Attributable to target vessel (TV-MI); Not attributable to target vessel (NTV-MI)	180 days
Number of Participants With Myocardial Infarction (MI)	Attributable to target vessel (TV-MI); Not attributable to target vessel (NTV-MI)	270 days
Number of Participants With Myocardial Infarction (MI)	Attributable to target vessel (TV-MI); Not attributable to target vessel (NTV-MI)	1 year
Number of Participants With Myocardial Infarction (MI)	Attributable to target vessel (TV-MI); Not attributable to target vessel (NTV-MI)	2 years
Number of Participants With Myocardial Infarction (MI)	Attributable to target vessel (TV-MI); Not attributable to target vessel (NTV-MI)	3 years
Number of Participants With Myocardial Infarction (MI)	Attributable to target vessel (TV-MI); Not attributable to target vessel (NTV-MI)	4 years
Number of Participants With Myocardial Infarction (MI)	Attributable to target vessel (TV-MI); Not attributable to target vessel (NTV-MI)	5 years
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)	Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)	In-hospital (≤ 7 days post index procedure)
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)	Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)	30 days
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)	Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)	90 days
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)	Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)	180 days
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)	Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)	270 days
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)	Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)	1 year
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)	Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)	2 year
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)	Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)	3 years
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)	Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)	4 years
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)	Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)	5 years
Number of Participants With Target Lesion Revascularization (TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.	In-hospital (≤ 7 days post index procedure)
Number of Participants With Target Lesion Revascularization (TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.	30 days
Number of Participants withTarget Lesion Revascularization (TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.	90 days
Number of Participants With Target Lesion Revascularization (TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.	180 days
Number of Participants With Target Lesion Revascularization (TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.	270 days
Number of Participants With Target Lesion Revascularization (TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.	1 year
Number of Participants With Target Lesion Revascularization (TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.	2 years
Number of Participants With Target Lesion Revascularization (TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.	3 years
Number of Participants With Target Lesion Revascularization (TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.	4 years
Number of Participants With Target Lesion Revascularization (TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.	5 years
Number of Participants With Ischemia Driven TLR (ID-TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography	In-hospital (≤ 7 days post index procedure)
Number of Participants With Ischemia Driven TLR (ID-TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography	30 days
Number of Participants With Ischemia Driven TLR (ID-TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography	90 days
Number of Participants With Ischemia Driven TLR (ID-TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography	180 days
Number of Participants With Ischemia Driven TLR (ID-TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography	270 days
Number of Participants With Ischemia Driven TLR (ID-TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography	1 year
Number of Participants With Ischemia Driven TLR (ID-TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography	2 years
Number of Participants With Ischemia Driven TLR (ID-TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography	3 years
Number of Participants With Ischemia Driven TLR (ID-TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography	4 years
Number of Participants With Ischemia Driven TLR (ID-TLR)	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography	5 years
Number of Participants With Target Vessel Revascularization (TVR)	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.; TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.; TVR includes all TVR, excluding TLR	In-hospital (≤ 7 days post index procedure)
Number of Participants With Target Vessel Revascularization (TVR)	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.; TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.; TVR includes all TVR, excluding TLR	30 days
Number of Participants With Target Vessel Revascularization (TVR)	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.; TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.; TVR includes all TVR, excluding TLR	90 days
Number of Participants With Target Vessel Revascularization (TVR)	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. classified as: Ischemic driven TVR and Non-ischemic driven TVR. -TVR includes all TVR, excluding TLR	180 days
Number of Participants With Target Vessel Revascularization (TVR)	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.; TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.; TVR includes all TVR, excluding TLR	270 days
Number of Participants With Target Vessel Revascularization (TVR)	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.; TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.; TVR includes all TVR, excluding TLR	1 year
Number of Participants With Target Vessel Revascularization (TVR)	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.; TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.; TVR includes all TVR, excluding TLR	2 years
Number of Participants With Target Vessel Revascularization (TVR)	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.; TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.; TVR includes all TVR, excluding TLR	3 years
Number of Participants With Target Vessel Revascularization (TVR)	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.; TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.; TVR includes all TVR, excluding TLR	4 years
Number of Participants With Target Vessel Revascularization (TVR)	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.; TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.; TVR includes all TVR, excluding TLR	5 years
Number of Participants With ID-TVR Excluding TLR	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.; TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.; TVR includes all TVR, excluding TLR	In-hospital (≤ 7 days post index procedure)
Number of Participants With ID-TVR Excluding TLR	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.; TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.; TVR includes all TVR, excluding TLR	30 days
Number of Participants With ID-TVR Excluding TLR	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.; TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.; TVR includes all TVR, excluding TLR	90 days
Number of Participants With ID-TVR Excluding TLR	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.; TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.; TVR includes all TVR, excluding TLR	180 days
Number of Participants With ID-TVR Excluding TLR	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.; TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.; TVR includes all TVR, excluding TLR	270 days
Number of Participants With ID-TVR Excluding TLR	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.; TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.; TVR includes all TVR, excluding TLR	1 year
Number of Participants With ID-TVR Excluding TLR	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.; TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.; TVR includes all TVR, excluding TLR	2 years
Number of Participants With ID-TVR Excluding TLR	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.; TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.; TVR includes all TVR, excluding TLR	3 years
Number of Participants With ID-TVR Excluding TLR	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.; TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.; TVR includes all TVR, excluding TLR	4 years
Number of Participants With ID-TVR Excluding TLR	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.; TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.; TVR includes all TVR, excluding TLR	5 years
Number of Participants With All Coronary Revascularization	Revascularization includes TLR, TVR excluding TLR, and non TVR.	In-hospital (≤ 7 days post index procedure)
Number of Participants With All Coronary Revascularization	Revascularization includes TLR, TVR excluding TLR, and non TVR.	30 days
Number of Participants With All Coronary Revascularization	Revascularization includes TLR, TVR excluding TLR, and non TVR.	90 days
Number of Participants With All Coronary Revascularization	Revascularization includes TLR, TVR excluding TLR, and non TVR.	180 days
Number of Participants With All Coronary Revascularization	Revascularization includes TLR, TVR excluding TLR, and non TVR.	270 days
Number of Participants With All Coronary Revascularization	Revascularization includes TLR, TVR excluding TLR, and non TVR.	1 year
Number of Participants With All Coronary Revascularization	Revascularization includes TLR, TVR excluding TLR, and non TVR.	2 years
Number of Participants With All Coronary Revascularization	Revascularization includes TLR, TVR excluding TLR, and non TVR.	3 years
Number of Participants With All Coronary Revascularization	Revascularization includes TLR, TVR excluding TLR, and non TVR.	4 years
Number of Participants With All Coronary Revascularization	Revascularization includes TLR, TVR excluding TLR, and non TVR.	5 years
Number of Participants Experienced All Death/All MI	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI	In-hospital (≤ 7 days post index procedure)
Number of Participants Experienced All Death/All MI	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI	30 days
Number of Participants Experienced All Death/All MI	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI	90 days
Number of Participants Experienced All Death/All MI	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI	180 days
Number of Participants Experienced All Death/All MI	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI	270 days
Number of Participants Experienced All Death/All MI	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI	1 year
Number of Participants Experienced All Death/All MI	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI	2 years
Number of Participants Experienced All Death/All MI	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI	3 years
Number of Participants Experienced All Death/All MI	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI	4 years
Number of Participants Experienced All Death/All MI	All deaths includes; Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.; Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.; Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI	5 years
Number of Participants Experienced Cardiac Death/All MI	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.	In-hospital (≤ 7 days post index procedure)
Number of Participants Experienced Cardiac Death/All MI	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.	30 days
Number of Participants Experienced Cardiac Death/All MI	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.	90 days
Number of Participants Experienced Cardiac Death/All MI	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.	180 days
Number of Participants Experienced Cardiac Death/All MI	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.	270 days
Number of Participants Experienced Cardiac Death/All MI	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.	1 year
Number of Participants Experienced Cardiac Death/All MI	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.	2 years
Number of Participants Experienced Cardiac Death/All MI	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.	3 years
Number of Participants Experienced Cardiac Death/All MI	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.	4 years
Number of Participants Experienced Cardiac Death/All MI	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.	5 years
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	In-hospital (≤ 7 days post index procedure)
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	30 days
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	90 days
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	180 days
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	270 days
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	1 year
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	2 years
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	3 years
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	4 years
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).	5 years
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	In-hospital (≤ 7 days post index procedure)
Number of Participants Experienced With Cardiac Death/All MI/ID-TLR (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	30 days
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	90 days
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	180 days
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	270 days
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	1 year
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	2 years
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	3 years
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	4 years
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).	5 years
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (Target Vessel Failure, TVF)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).	In-hospital (≤ 7 days post index procedure)
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).	30 days
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).	90 days
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).	180 days
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).	270 days
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).	1 year
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).	2 years
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).	3 years
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).	4 years
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).	5 years
Number of Participants Experienced Death/All MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	In-hospital (≤ 7 days post index procedure)
Number of Participants Experienced Death/All MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	30 days
Number of Participants Experienced Death/All MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	90 days
Number of Participants Experienced Death/All MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	180 days
Number of Participants Experienced Death/All MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	270 days
Number of Participants Experienced Death/All MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	1 year
Number of Participants Experienced Death/All MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	2 years
Number of Participants Experienced Death/All MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	3 years
Number of Participants Experienced Death/All MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	4 years
Number of Participants Experienced Death/All MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	5 years
Number of Participants With Acute Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition)	Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).	0 - 24 hours post stent implantation
Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition)	Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).	>24 hours - 30 days post stent implantation
Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition)	Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).	30 days - 1 year post stent implantation
Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition)	Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained	0 to 730 Days
Number of Participants With Rehospitalization	Coronary artery disease (CAD) related; Cardiovascular, non-CAD related; Non-cardiovascular related	30 days
Number of Participants With Rehospitalization	CAD related; Cardiovascular, non-CAD related; Non-cardiovascular related	90 days
Number of Participants With Rehospitalization	CAD related; Cardiovascular, non-CAD related; Non-cardiovascular related	180 days
Number of Participants With Rehospitalization	CAD related; Cardiovascular, non-CAD related; Non-cardiovascular related	270 days
Number of Participants With Rehospitalization	CAD related; Cardiovascular, non-CAD related; Non-cardiovascular related	1 year
Number of Participants With Rehospitalization	CAD related; Cardiovascular, non-CAD related; Non-cardiovascular related	2 years
Number of Participants With Rehospitalization	CAD related; Cardiovascular, non-CAD related; Non-cardiovascular related	3 years
Number of Participants With Rehospitalization	CAD related; Cardiovascular, non-CAD related; Non-cardiovascular related	4 years
Number of Participants With Rehospitalization	CAD related; Cardiovascular, non-CAD related; Non-cardiovascular related	5 years
Number of Participants With Repeat Coronary Arteriography		In-hospital (≤ 7 days post index procedure)
Number of Participants With Repeat Coronary Arteriography		30 days
Number of Participants With Repeat Coronary Arteriography		90 days
Number of Participants With Repeat Coronary Arteriography		180 days
Number of Participants With Repeat Coronary Arteriography		270 days
Number of Participants With Repeat Coronary Arteriography		1 year
Number of Participants With Repeat Coronary Arteriography		2 years
Number of Participants With Repeat Coronary Arteriography		3 years
Number of Participants With Repeat Coronary Arteriography		4 years
Number of Participants With Repeat Coronary Arteriography		5 years
Number of Participants With Target Lesion Failure (TLF)	The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV)	1 year
Number of Death (Cardiac, Vascular, Non-cardiovascular)	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	3 years
Number of Death (Cardiac, Vascular, Non-cardiovascular)	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.	4 years
Number of Death (Cardiac, Vascular, Non-cardiovascular)	Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. For the All-Cause Mortality data, the denominator excludes participants who are lost-to-follow-up or withdrawn (by subject or physician) through a given timepoint without any DMR event (all death, MI and revascularization, respectively). If these participants were included in the denominator in each arm, that would equate to assuming that these participants are alive, potentially underestimating the death rate by inflating the denominator.	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcomes	Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life; EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.	Baseline
Patient Reported Outcomes	Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life; EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.	1 month
Patient Reported Outcomes	Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life; EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.	6 months
Patient Reported Outcomes	Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life; EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.	1 year
Patient Reported Outcomes	Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life; EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.	3 years
Patient Reported Outcomes (PRO)	Patient-reported outcomes (PRO) are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years. The following questionnaires will be used in this study: Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life; EuroQoL 5D (EQ-5D) survey to assess overall health status (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV) The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial. Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.	5 years
Landmark Analysis on TLF and Components	TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).	3-4 years
Landmark Analysis on TLF and Components	TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).	3-5 years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Chair: Gregg W Stone, MD, Columbia University Medical Center, New York, NY; Principal Investigator: Gregg W Stone, MD, Columbia University Medical Center, New York, NY; Principal Investigator: Stephen G Ellis, MD, Cleveland Clinic, Cleveland OH; Principal Investigator: Dean J Kereiakes, MD, The Christ Hospital, Cincinnati, OH

Publications and helpful links

General Publications

• Stone GW, Ellis SG, Gori T, Metzger DC, Stein B, Erickson M, Torzewski J, Williams J Jr, Lawson W, Broderick TM, Kabour A, Piegari G, Cavendish J, Bertolet B, Choi JW, Marx SO, Genereux P, Kereiakes DJ; ABSORB IV Investigators. Blinded outcomes and angina assessment of coronary bioresorbable scaffolds: 30-day and 1-year results from the ABSORB IV randomised trial. Lancet. 2018 Oct 27;392(10157):1530-1540. doi: 10.1016/S0140-6736(18)32283-9. Epub 2018 Sep 25. Erratum In: Lancet. 2019 Oct 5;394(10205):1230.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): April 6, 2022
• Study Completion (Actual): April 6, 2022

Study Registration Dates

• First Submitted: June 9, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimated): June 25, 2014

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Stents; Coronary Artery Disease; Everolimus; Angioplasty; Drug eluting stents; Myocardial ischemia; Stent thrombosis; Absorb™ BVS; Bioabsorbable; BVS; Coronary Artery Endothelial Responsiveness; Coronary artery restenosis; Coronary artery stenosis; Coronary scaffold; Coronary Stent
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Constriction, Pathologic; Coronary Stenosis
• Other Study ID Numbers: 10-392 C

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No