ABSORB III Randomized Controlled Trial (RCT) (ABSORB-III)

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

The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).

The ABSORB III includes additional two trials i.e. ABSORB III PK (pharmacokinetics) sub-study and ABSORB IV RCT trial which are maintained under one protocol because both trial designs are related, ABSORB IV is the continuation of ABSORB III and 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.

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 III RCT:

A. Primary Objective: The pivotal trial to support the US pre-market approval (PMA) of Absorb BVS. ABSORB III will evaluate the safety and effectiveness of the Absorb BVS System compared to the XIENCE in the treatment of subjects, including those with diabetes mellitus, with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

B. Powered Secondary Objectives:

1. Lead-In Phase Objective: To evaluate the applicability and transferability of the didactic Absorb BVS physician training plan to US clinical practice.

   The lead-in phase is a non-randomized, single-arm, open label group of up to 50 subjects treated with Absorb BVS at up to 35 US sites. The Lead-In phase will enroll/register subjects prior to the randomization phase of ABSORB III.

   The Lead-In Phase allows the treatment of up to two de novo native coronary artery lesions in different epicardial vessels with reference vessel diameter (RVD) ≥ 2.75 mm to ≤ 3.25 mm and lesion lengths ≥ 8 to ≤ 14 mm.

2. Imaging Cohort Objective: To evaluate long-term vascular function and patency of the Absorb BVS treated segments compared to XIENCE treated segments in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

The imaging cohort-phase is a prospective, randomized (2:1 Absorb BVS to XIENCE), single-blind, multi-center trial, registering approximately 200 subjects. This includes 150 subjects for the angiographic/intravascular ultrasound (IVUS) endpoints analysis and approximately 50 subjects for optical coherence tomography (OCT) endpoints analysis. The 200 subjects are separate from the 2000 subjects included in the primary analysis. Data from two powered secondary endpoints from this cohort will support label claims of superiority of Absorb BVS as compared to XIENCE specific to vasomotion and late lumen enlargement.

All other subjects in ABSORB III unless specified will receive treatment of up to two de novo native coronary artery lesions in different epicardial vessels with RVD ≥ 2.5 mm to ≤ 3.75 mm and lesion lengths ≤ 24 mm.

• Study Type: Interventional
• Enrollment (Actual): 2008
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • St. Vincent's Hospital Melbourne
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Baptist Medical Center Princeton
    • Birmingham, Alabama, United States, 35233
      • University of Alabama Hospital
    • Fairhope, Alabama, United States, 36532
      • Thomas Hospital
    • Montgomery, Alabama, United States, 36117
      • Baptist Medical Center South
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Chandler Regional Medical Center
    • Mesa, Arizona, United States, 85206
      • Banner Heart Hospital
    • Phoenix, Arizona, United States, 85006
      • Banner Good Samaritan Medical Center
    • Scottsdale, Arizona, United States, 85260
      • Scottsdale Healthcare
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • California
    • Concord, California, United States, 94520
      • John Muir Medical Center - Concord Campus
    • Fremont, California, United States, 94538
      • Washington Hospital
    • La Jolla, California, United States, 92037
      • Scripps Green Hospital
    • La Jolla, California, United States, 92037
      • Scripps Memorial Hospital
    • Los Angeles, California, United States, 90017
      • Good Samaritan Hospital
    • Los Angeles, California, United States, 90043
      • Cedars-Sinai Medical Center
    • Modesto, California, United States, 95355
      • Sutter Central Valley Hospitals dba Memorial Medical Center
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center
    • Sacramento, California, United States, 95816
      • Mercy General Hospital
    • Sacramento, California, United States, 95819
      • Sutter Medical Center
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
    • Santa Barbara, California, United States, 93105
      • Santa Barbara Cottage Hospital
    • Stanford, California, United States, 94305
      • Stanford Hospital and Clinics
    • Torrance, California, United States, 90503
      • Little Company of Mary Hospital
    • Torrance, California, United States, 90505
      • Torrance Memorial Medical Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • UCH-Memorial Health Systems
    • Fort Collins, Colorado, United States, 80538
      • Medical Center of the Rockies
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale-New Haven Hospital
    • Stamford, Connecticut, United States, 06905
      • St. Vincent's Medical Center
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Health Services
  • Florida
    • Brandon, Florida, United States, 33511
      • Brandon Regional Hospital
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital
    • Hollywood, Florida, United States, 33021
      • Memorial Regional Hospital
    • Jacksonville, Florida, United States, 32204
      • St. Vincent's Medical Center
    • Jacksonville, Florida, United States, 32207
      • Baptist Medical Center - Downtown
    • Jacksonville, Florida, United States, 32209
      • University of Florida UF Health
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
    • Miami, Florida, United States, 33136
      • University of Miami Hospital
    • Ocala, Florida, United States, 34471
      • MediQuest Research Group Inc at Munroe Regional Medical Center
    • Orlando, Florida, United States, 32803
      • Florida Hospital
    • Palm Beach Gardens, Florida, United States, 33410
      • Palm Beach Gardens Medical Center
    • Panama City, Florida, United States, 32401
      • Bay County Health Systems
    • Pensacola, Florida, United States, 32501
      • Baptist Hospital
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
    • Tampa, Florida, United States, 33613
      • Florida Hospital Pepin Heart Institute
    • Tampa, Florida, United States, 33609
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital
    • Atlanta, Georgia, United States, 30342
      • Saint Joseph's Hospital of Atlanta
    • Augusta, Georgia, United States, 30901
      • University Hospital
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Medical Center
    • Marietta, Georgia, United States, 30060
      • Wellstar Kennestone Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
    • Peoria, Illinois, United States, 61614
      • Saint Francis Medical Center
    • Springfield, Illinois, United States, 62701
      • St. John's Hospital
  • Indiana
    • Elkhart, Indiana, United States, 46514
      • Elkhart General Healthcare
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Methodist Hospital
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent Heart Center of Indiana
    • Indianapolis, Indiana, United States, 46237
      • Franciscan St. Francis Health
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Genesis Medical Center
    • West Des Moines, Iowa, United States, 50266
      • Mercy Medical
  • Kansas
    • Kansas City, Kansas, United States, 66106
      • The University of Kansas Hospital and Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Medical Center
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
    • Louisville, Kentucky, United States, 40202
      • Jewish Hospital
  • Maine
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • MedStar Washington Hospital Center
    • Hyattsville, Maryland, United States, 20782
      • Union Memorial Hospital
    • Salisbury, Maryland, United States, 21804
      • Peninsula Regional Medical Center
    • Takoma Park, Maryland, United States, 20912
      • Washington Adventist Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02118
      • Boston University Medical Center
    • Brighton, Massachusetts, United States, 02135
      • St. Elizabeth's Medical Center of Boston
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center
  • Michigan
    • Bay City, Michigan, United States, 48708
      • Bay Regional Medical Center
    • Dearborn, Michigan, United States, 48124
      • Oakwood Hospital and Medical Center
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48201
      • Harper University Hospital
    • Detroit, Michigan, United States, 48236
      • St. John Hospital & Medical Center
    • Kalamazoo, Michigan, United States, 49048
      • Borgess Medical Center
    • Lansing, Michigan, United States, 48910
      • Sparrow Hospital
    • Petoskey, Michigan, United States, 49770
      • Northern Michigan Hospital
    • Royal Oak, Michigan, United States, 48703
      • William Beaumont Hospital
    • Traverse City, Michigan, United States, 49684
      • Munson Medical Center
    • Ypsilanti, Michigan, United States, 48197
      • St. Joseph Mercy Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital
    • Robbinsdale, Minnesota, United States, 55422
      • North Memorial Medical Center
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center Cardiology Associates Research, LLC
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Boone Hospital Center
    • Saint Louis, Missouri, United States, 63110
      • Barnes Jewish Hospital
    • Saint Louis, Missouri, United States, 63129
      • St. Anthony's Medical Center
    • Springfield, Missouri, United States, 65807
      • Mercy Hospital Springfield
  • Montana
    • Missoula, Montana, United States, 59802
      • St. Patrick Hospital
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Nebraska Heart Hospital
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Hospital and Medical Center
    • Haddon Heights, New Jersey, United States, 08035
      • Cooper University Hospital
    • Haddon Heights, New Jersey, United States, 08035
      • Our Lady of Lourdes Medical Center
    • Morristown, New Jersey, United States, 07962
      • Morristown Medical Center
    • Neptune, New Jersey, United States, 07753
      • Jersey Shore University Medical Center
    • Paterson, New Jersey, United States, 07503
      • St. Joseph's Regional Medical Center
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Presbyterian Hospital
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Liverpool, New York, United States, 13088
      • St. Joseph's Hospital Health Center
    • Manhasset, New York, United States, 11030
      • Long Island Jewish Medical Center
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital
    • 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, 10065
      • New York Presbyterian Hospital-Cornell University
    • New York, New York, United States, 10075
      • Lennox Hill Hospital,
    • Rochester, New York, United States, 14621
      • Rochester General Hospital
    • Rochester, New York, United States, 14627
      • Strong Memorial Hospital
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • Charlotte, North Carolina, United States, 28204
      • Presbyterian Hospital
    • Durham, North Carolina, United States, 27110
      • Duke University Medical Center
    • Raleigh, North Carolina, United States, 27607
      • Rex Hospital
    • Raleigh, North Carolina, United States, 27610
      • WakeMed
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Forsyth Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Baptist Medical Center
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Hospital
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Cincinnati, Ohio, United States, 45242
      • Bethesda North Hospital
    • Cincinnati, Ohio, United States, 45206
      • University Hospital
    • Cincinnati, Ohio, United States, 45220
      • Tri-Health Good Samaritan Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
    • Elyria, Ohio, United States, 44035
      • EMH Healthcare
    • Fairview Park, Ohio, United States, 44126
      • Cleveland Cln Fairview Hospital
    • Kettering, Ohio, United States, 45429
      • Kettering Medical Center
    • Toledo, Ohio, United States, 43606
      • The Toledo Hospital
    • Toledo, Ohio, United States, 43608
      • Mercy St. Vincent's Medical Center
    • Zanesville, Ohio, United States, 43701
      • Genesis-Good Samaritan Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Heart Hospital
    • Oklahoma City, Oklahoma, United States, 73112
      • Integris Baptist Medical Center
    • Tulsa, Oklahoma, United States, 74104
      • Hillcrest Medical Center
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
    • Springfield, Oregon, United States, 97477
      • PeaceHealth Sacred Heart Medical Center
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Memorial Hospital
    • Camp Hill, Pennsylvania, United States, 17011
      • Holy Spirit Hospital
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Hospital
    • Erie, Pennsylvania, United States, 16550
      • UPMC Hamot
    • Langhorne, Pennsylvania, United States, 19047
      • St. Mary Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Pennsylvania Hospital
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Presbyterian
    • Pittsburgh, Pennsylvania, United States, 15219
      • UPMC Shadyside Hospital
    • Wormleysburg, Pennsylvania, United States, 17043
      • Pinnacle Health at Harrisburg Hospital
    • Wyomissing, Pennsylvania, United States, 19610
      • St. Joseph Medical Center
    • York, Pennsylvania, United States, 17405
      • York Hospital
  • 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
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Columbia, South Carolina, United States, 29204
      • Sisters of Charity Providence Hospital
    • Greenville, South Carolina, United States, 29605
      • Greenville Memorial Hospital of the Greenville Health System
    • Greenville, South Carolina, United States, 29607
      • St. Francis Health System
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford USD Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Memorial Hospital
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Holston Valley Medical Center
    • Knoxville, Tennessee, United States, 37934
      • Turkey Creek 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 Austin
    • Dallas, Texas, United States, 75204
      • Baylor Jack and Jane Hamilton Heart and Vascular Hospital
    • Houston, Texas, United States, 77030
      • The Methodist Hospital Research Institute
    • Houston, Texas, United States, 77030
      • St. Luke's Episcopal Hospital
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano
    • San Antonio, Texas, United States, 78201
      • Methodist Texsan Hospital
    • Tyler, Texas, United States, 75701
      • East Texas Medical Center
    • Tyler, Texas, United States, 75701
      • Trinity Mother Frances Hospital Regional Healthcare Center
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Fletcher Allen Health Care
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
    • Fredericksburg, Virginia, United States, 22401
      • Mary Washington Hospital
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
    • Roanoke, Virginia, United States, 24014
      • Carilion Roanoke Memorial Hospital
    • Winchester, Virginia, United States, 22601
      • Winchester Medical Center
  • Washington
    • Bellingham, Washington, United States, 98225
      • St. Joseph Hospital
    • Everett, Washington, United States, 98201
      • Providence Regional Medical Center Everett
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • St. Mary's Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's Medical 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., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI. Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objectives sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG). In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia.
4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
5. 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.
6. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
7. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 1 year following the index procedure.

Angiographic Inclusion Criteria:

1. One or two de novo target lesions:

   1. If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion.
   2. If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.
   3. The definition of epicardial vessels means the LAD, LCX and RCA and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch.

2. 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 TIMI flow of ≥ 1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve, stress test), unstable angina or post-infarct angina.

   1. Lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.
   2. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.
   3. For Lead-In subjects with 3.0x18 mm Absorb BVS: lesions (s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.75 mm and ≤ 3.25 mm. The lesion length by visual estimation is ≥ 8 mm and ≤ 14 mm.

General Exclusion Criteria:

1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist 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 aspirin; or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
4. Subject had an acute myocardial infarction (AMI; STEMI or NSTEMI) within 72 hours of the index procedure and both CK and CK-MB have not returned to within normal limits at the time of index procedure; or subject with stable angina or silent ischemia has CK-MB that is greater than normal limits at the time of the index procedure.
5. Subject is currently experiencing clinical symptoms consistent with new onset AMI (STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.

6. Subject has a cardiac arrhythmia as 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.
7. 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 ACS, LVEF must be assessed during the index hospitalization (which may include during the index procedure by contrast left ventriculography) but prior to randomization in order to confirm the subject's eligibility.
8. 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 24 hours and 30 days before the index procedure if successful and uncomplicated.
9. Subject requires future staged PCI either in target or non-target vessels or subject requires future peripheral interventions < 30 days after the index procedure
10. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
11. At the time of screening, the subject has a malignancy that is not in remission.
12. 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.
13. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
14. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban or any other agent for any reason).
15. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
16. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
17. Subject has renal insufficiency as defined as an estimated GFR < 30 ml/min/1.73m2 or dialysis at the time of screening.
18. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months.
19. 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.).
20. 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.
21. Subject has life expectancy < 5 years for any non-cardiac cause or cardiac cause.
22. 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.
23. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
24. 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 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. Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes:

   1. Residual %DS is a maximum < 40% (per visual estimation), ≤ 20% is strongly recommended.
   2. TIMI Grade-3 flow (per visual estimation).
   3. No angiographic complications (e.g. distal embolization, side branch closure).
   4. No dissections NHLBI grade D-F.
   5. No chest pain lasting > 5 minutes.
   6. No ST depression or elevation lasting > 5 minutes.
2. Lesion is located in left main.
3. Aorto-ostial RCA lesion (within 3 mm of the ostium).
4. Lesion located within 3 mm of the origin of the LAD or 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 IVUS used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.
7. Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.
8. Lesion or vessel involves a myocardial bridge.
9. Vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS or XIENCE would need to cross the stent to reach the target lesion.
10. Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.
11. 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 BVS	Device: Absorb BVS; Scaffold diameters: 2.5, 3.0 and 3.5 mm; Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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.; 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	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; Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition; 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 Cardiac Death/TV-MI/ID-TLR (TLF)	TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Powered Secondary Endpoint: Angina	Angina is defined as the first adverse event resulting in the site diagnosis of angina.	1 year
Number of Participants With Powered Secondary Endpoint: All Revascularization	This powered secondary endpoint is intended to assess all revascularization at 1 year and test for superiority of Absorb BVS to XIENCE. All revascularizations are comprised of TLR, TVR excluding TLR, and non-TVR.	1 year
Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR)	This powered secondary endpoint is intended to assess all ID-TVR at 1 year and test for superiority of Absorb BVS to XIENCE.	1 year
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.	On day 0 (the day of procedure)
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).	On day 0 (the day of procedure)
Number of Death (Cardiac, Vascular, Non-cardiovascular)	DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. 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. 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.	0 to 5 years
Number of Participants With All Myocardial Infarction (MI)	Attributable to target vessel (TV-MI); Not attributable to target vessel (NTV-MI)	0 to 5 years
Number of Participants With All 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 (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.	0 to 5 years
Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (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.	0 to 5 years
Number of Participants With All Revascularization	All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.	0 to 5 years
Number of 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	0 to 5 years
Number of Cardiac 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	0 to 5 years
Number of 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).	0 to 5 years
Number of 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).	0 to 5 years
Number of Participants With 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).	0 to 5 years
Number of Death/All MI/All Revascularization (DMR)	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.	0 to 5 years
Number of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition)	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.	≤ 1 Day
Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis (Per ARC Definition)	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.	0 to 30 Days
Number of Participants With Subacute Stent/Scaffold Thrombosis	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.	>1 to 30 Days
Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of; Any unexplained death within the first 30 days or; Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.	31 to 365 Days
Number of Participants With Very Late Stent /Scaffold Thrombosis (Per ARC Definition)	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of; Any unexplained death within the first 30 days or; Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.	366 to 393 Days
Number of Participants With Cumulative Stent/Scaffold Thrombosis	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of; Any unexplained death within the first 30 days or; Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.	0 to 1853 Days
Pre-Procedure Minimum Lumen Diameter (MLD)	Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.	< or = 1 day
Pre-Procedure Percent Diameter Stenosis (%DS)	Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).	< or = 1 day
Post-Procedure In-Segment Minimum Lumen Diameter (MLD)	Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.	≤ 7 days post index procedure
Post-Procedure In-Segment Percent Diameter Stenosis (%DS)	Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.	≤ 7 days post index procedure
Post-Procedure In-Device Minimum Lumen Diameter (MLD)	Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold	≤ 7 days post index procedure
Post-Procedure In-Device Percent Diameter Stenosis (%DS)	Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).	≤ 7 days post index procedure
Post-Procedure In-Device Acute Gain	The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).	≤ 7 days post index procedure
Powered Imaging Cohort Secondary Endpoint: The Instent/Scaffold Mean Lumen Area Change, From Post Procedure to 3 Years by Intravascular Ultrasound (IVUS)	Mean lumen area measured after nitrate infusions, superiority test, ~300 pooled subjects.; Pooled IVUS subjects (~300 subjects): 150 subjects from the Imaging Cohort of ABSORB III RCT and 150 subjects from ABSORB Japan RCT.	From Post procedure to 3 Years
Optical Coherence Tomography (OCT) Endpoint: Mean Neointimal Area (NIA)	All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions	3 Years
Optical Coherence Tomography (OCT) Endpoint: Mean Device Area, Adluminal	All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions	3 Years
Optical Coherence Tomography (OCT) Endpoint: Mean Lumen Area	All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions	3 Years
Optical Coherence Tomography (OCT) Endpoint: Minimal Lumen Area	All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions	3 Years
Optical Coherence Tomography (OCT) Endpoint: Percentage of Malapposition Struts	All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions	3 Years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcomes (PRO): Overall Health Status	Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: Scale range: 0 to 1; Higher values represent better outcomes; Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1	Baseline
Patient Reported Outcomes (PRO): Overall Health Status	Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: Scale range: 0 to 1; Higher values represent better outcomes; Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1	1 month
Patient Reported Outcomes (PRO): Overall Health Status	Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: Scale range: 0 to 1; Higher values represent better outcomes; Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1	12 months
Patient Reported Outcomes (PRO): Anxiety	Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: Scale range: 0 to 21; Lower values represent better outcomes; No subscales	Baseline
Patient Reported Outcomes (PRO): Anxiety	Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: Scale range: 0 to 21; Lower values represent better outcomes; No subscales	1 month
Patient Reported Outcomes (PRO): Anxiety	Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: Scale range: 0 to 21; Lower values represent better outcomes; No subscales	12 months
Patient Reported Outcomes (PRO): Disease-Specific Quality of Life	Disease-Specific quality of life assessed using the Seattle Angina Questionnaire (SAQ) Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).	Baseline
Patient Reported Outcomes (PRO): Disease-Specific Quality of Life	Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ). Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).	1 month
Patient Reported Outcomes (PRO): Disease-Specific Quality of Life	Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ). Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).	12 months
Patient Reported Outcomes (PRO): Dyspnea Severity	Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: Scale range: 0 to 4; Lower values represent better outcomes (higher scores indicate worse dyspnea); No subscales	Baseline
Patient Reported Outcomes (PRO): Dyspnea Severity	Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: Scale range: 0 to 4; Lower values represent better outcomes (higher scores indicate worse dyspnea); No subscales	1 month
Patient Reported Outcomes (PRO): Dyspnea Severity	Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: Scale range: 0 to 4; Lower values represent better outcomes (higher scores indicate worse dyspnea); No subscales	12 months
Landmark Analysis on TLF and Components	TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TVMI), or Ischemic-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 (per protocol-defined MI definition), attributable to Target Vessel (TVMI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).	3-5 years
Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of; Any unexplained death within the first 30 days or; Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.	3-4 years
Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of; Any unexplained death within the first 30 days or; Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.	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: Stephen G Ellis, MD, Cleveland Clinic, Cleveland OH; Principal Investigator: Dean J Kereiakes, MD, The Christ Hospital, Cincinnati, OH; Study Director: Jennifer McMeans Jones, Abbott Medical Devices

Publications and helpful links

General Publications

• Nishi T, Okada K, Kitahara H, Kameda R, Ikutomi M, Imura S, Hollak MB, Yock PG, Popma JJ, Kusano H, Cheong WF, Sudhir K, Fitzgerald PJ, Ellis SG, Kereiakes DJ, Stone GW, Honda Y, Kimura T; ABSORB III and ABSORB Japan Investigators. Intravascular ultrasound predictors of long-term outcomes following ABSORB bioresorbable scaffold implantation: A pooled analysis of the ABSORB III and ABSORB Japan trials. J Cardiol. 2021 Sep;78(3):224-229. doi: 10.1016/j.jjcc.2021.03.005. Epub 2021 Apr 21.
• Stone GW, Kimura T, Gao R, Kereiakes DJ, Ellis SG, Onuma Y, Chevalier B, Simonton C, Dressler O, Crowley A, Ali ZA, Serruys PW. Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and Individual Patient Data Pooled Study. JAMA Cardiol. 2019 Dec 1;4(12):1261-1269. doi: 10.1001/jamacardio.2019.4101.
• Kereiakes DJ, Ellis SG, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, Tan SH, Ediebah DE, Simonton C, Stone GW; ABSORB III Investigators. Clinical Outcomes Before and After Complete Everolimus-Eluting Bioresorbable Scaffold Resorption: Five-Year Follow-Up From the ABSORB III Trial. Circulation. 2019 Dec 3;140(23):1895-1903. doi: 10.1161/CIRCULATIONAHA.119.042584. Epub 2019 Sep 25.
• Kereiakes DJ, Ellis SG, Metzger C, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, McGreevy R, Zhang Z, Simonton C, Stone GW; ABSORB III Investigators. 3-Year Clinical Outcomes With Everolimus-Eluting Bioresorbable Coronary Scaffolds: The ABSORB III Trial. J Am Coll Cardiol. 2017 Dec 12;70(23):2852-2862. doi: 10.1016/j.jacc.2017.10.010. Epub 2017 Oct 31.
• Ali ZA, Gao R, Kimura T, Onuma Y, Kereiakes DJ, Ellis SG, Chevalier B, Vu MT, Zhang Z, Simonton CA, Serruys PW, Stone GW. Three-Year Outcomes With the Absorb Bioresorbable Scaffold: Individual-Patient-Data Meta-Analysis From the ABSORB Randomized Trials. Circulation. 2018 Jan 30;137(5):464-479. doi: 10.1161/CIRCULATIONAHA.117.031843. Epub 2017 Oct 31.
• Baron SJ, Lei Y, Chinnakondepalli K, Vilain K, Magnuson EA, Kereiakes DJ, Ellis SG, Stone GW, Cohen DJ; ABSORB III Investigators. Economic Outcomes of Bioresorbable Vascular Scaffolds Versus Everolimus-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: 1-Year Results From the ABSORB III Trial. JACC Cardiovasc Interv. 2017 Apr 24;10(8):774-782. doi: 10.1016/j.jcin.2017.01.022.
• Stone GW, Gao R, Kimura T, Kereiakes DJ, Ellis SG, Onuma Y, Cheong WF, Jones-McMeans J, Su X, Zhang Z, Serruys PW. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016 Mar 26;387(10025):1277-89. doi: 10.1016/S0140-6736(15)01039-9. Epub 2016 Jan 27.
• Ellis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, McGreevy R, Zhang Z, Simonton C, Stone GW; ABSORB III Investigators. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med. 2015 Nov 12;373(20):1905-15. doi: 10.1056/NEJMoa1509038. Epub 2015 Oct 12.
• Kereiakes DJ, Ellis SG, Popma JJ, Fitzgerald PJ, Samady H, Jones-McMeans J, Zhang Z, Cheong WF, Su X, Ben-Yehuda O, Stone GW. Evaluation of a fully bioresorbable vascular scaffold in patients with coronary artery disease: design of and rationale for the ABSORB III randomized trial. Am Heart J. 2015 Oct;170(4):641-651.e3. doi: 10.1016/j.ahj.2015.07.013. Epub 2015 Jul 26.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: December 13, 2012
• First Submitted That Met QC Criteria: December 14, 2012
• First Posted (Estimated): December 18, 2012

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: January 1, 2021

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; Bioresorbable
• 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