SPIRIT PRIME Clinical Trial (SPIRIT PRIME)

SPIRIT PRIME Clinical Trial.

To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter in subjects with symptomatic heart disease due to a maximum of two de novo native coronary artery lesions, each in a different epicardial vessel.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Coronary Artery Disease; Coronary Disease; Coronary Restenosis; Coronary Artery Stenosis
• Intervention / Treatment: Device: Core size Xience Prime; Device: Xience Prime Long Lesion (LL)

• Study Type: Interventional
• Enrollment (Actual): 525
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Auchenflower, Queensland, Australia
      • Wesley Hospital
    • Chermside, Queensland, Australia, 4061
      • The Prince Charles Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Heart
    • Melbourne, Victoria, Australia, 3065
      • St. Vincent's Hospital
    • Richmond, Victoria, Australia, 3121
      • Epworth Hospital
  • Western Australia
    • Perth, Western Australia, Australia
      • Royal Perth Hospital
• United States
  • Alabama
    • Fairhope, Alabama, United States, 36532
      • Thomas Hospital
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Scottsdale Healthcare
  • California
    • Sacramento, California, United States, 95819
      • Mercy General Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Clearwater, Florida, United States, 33765
      • Morton Plant Hospital
    • Jacksonville, Florida, United States, 32204
      • St. Vincents Medical Center
    • Orlando, Florida, United States, 32806
      • Orlando Regional Medical Center
    • Pensacola, Florida, United States, 32504-8721
      • Sacred Heart Hospital of Pensicola
  • Illinois
    • Springfield, Illinois, United States, 62701
      • St. John's Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Heart Center of Indiana
  • Iowa
    • West Des Moines, Iowa, United States, 50314
      • Iowa Heart Center P.C.
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Hospital
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Willis Knighton Health System, Pierremont
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
    • Baltimore, Maryland, United States, 21218
      • Union Memorial Hospital
    • Salisbury, Maryland, United States, 21801
      • Peninsula Regional Medical Center
    • Takoma Park, Maryland, United States, 20912
      • Washington Adventist Hospital
  • Massachusetts
    • Hyannis, Massachusetts, United States, 02601
      • Cape Cod Hospital
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Bay Regional Medical Center
    • Kalamazoo, Michigan, United States, 49048
      • Borgess Medical Center
    • Petoskey, Michigan, United States, 49770
      • Northern Michigan Hospital
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital
    • St. Louis, Missouri, United States, 63110
      • Barnes Jewish Hospital
  • Montana
    • Missoula, Montana, United States, 59802
      • St. Patrick Hospital
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper Health System
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
  • New York
    • NY, New York, United States, 10029
      • Mount Sinai Medical Center
    • New York, New York, United States, 10011
      • Gotham Cardiology
  • North Carolina
    • Charlotte, North Carolina, United States, 28233
      • Presbyterian Hospital - Charlotte
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Baptist Medical Center
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital
    • Elyria, Ohio, United States, 44035
      • EMH Regional Medical Center
    • Toledo, Ohio, United States, 43608
      • St. Vincent Mercy Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Hillcrest Medical Center
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Harrisburg, Pennsylvania, United States, 17043
      • Pinnacle Health @ Harrisburg Hospital
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • AnMed Health
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford USD Medical Center
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Holston Valley Medical Center
  • Texas
    • Amarillo, Texas, United States, 79106
      • Northwest Texas Healthcare System
    • Austin, Texas, United States, 78756
      • Heart Hospital of Austin
    • Houston, Texas, United States, 77030
      • St. Luke's Episcopal Hospital
    • Pearland, Texas, United States, 77581
      • The Methodist Hospital
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Fletcher Allen Health Care
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Washington
    • Bellevue, Washington, United States, 98004
      • Overlake Hospital Medical Center
    • Bellingham, Washington, United States, 98225
      • St. Joseph Hospital
    • Spokane, Washington, United States, 99204
      • Heart Clinics Northwest/ Sacred Heart 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
• Genders Eligible for Study: All

Description

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 or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
5. Subject must agree to undergo all protocol-required follow-up procedures.
6. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.

Angiographic Inclusion Criteria

1. One or two de novo target lesions each in a different epicardial vessel.

2. If there are two target lesions, both lesions must satisfy the angiographic eligibility criteria for that registry.

   o Multiple focal de novo lesions in a target vessel that can be covered by a single stent are allowed.

3. The target lesion(s) must be located in a major artery or branch with a visually estimated diameter stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1.

4. Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of:

   • ≥ 2.25 mm and ≤ 4.25 mm for treatment by the core size XIENCE PRIME EECS
   • ≥ 2.5 mm and ≤ 4.25 mm for treatment by the XIENCE PRIME LL EECS

5. Target lesion(s) must be located in a native coronary artery with length by visual estimation of:

   • ≤ 22 mm for treatment by the core size XIENCE PRIME EECS
   • > 22 mm and ≤ 32 mm for treatment by the XIENCE PRIME LL EECS

Exclusion Criteria:

1. Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned to within normal limits at the time of procedure.
2. The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
3. Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.
4. Subject has a known left ventricular ejection fraction (LVEF) < 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
5. Subject has received coronary brachytherapy in any epicardial vessel (target or non target).
6. Subject has received any organ transplant or is on a waiting list for any organ transplant.
7. Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.
8. Subject is receiving or scheduled to receive planned radiotherapy to the chest/mediastinum.
9. Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.).
10. Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).
11. Subject will require Low Molecular Weight Heparin (LMWH) post-procedure.
12. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
13. Elective surgery is planned within 12 months after the procedure that will require discontinuing either aspirin or clopidogrel.
14. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell (WBC) of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
15. Subject has known renal insufficiency (examples being but not limited to estimated glomerular filtration rate (eGFR) < 60 ml/kg/m2, serum creatinine level ≥ 2.5 mg/dL, or on dialysis).
16. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
17. Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.
18. Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.
19. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
20. Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
21. Subject is currently participating in another clinical study that has not yet completed its primary endpoint.
22. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual estimation.

1. Target lesion located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion) arterial or saphenous vein graft.
2. Target lesion involving a bifurcation with a side branch ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed or side branch requiring protection guide wire, or side branch requiring dilatation.
3. Target lesion with total occlusion (TIMI flow 0), prior to crossing with the wire.
4. Another lesion requiring revascularization is located in the same epicardial vessel of the target lesion.
5. Restenotic target lesion.
6. Aorto-ostial target lesion (within 3 mm of the aorta junction).
7. Target lesion is in a left main location.
8. Target lesion located within 2 mm of the origin of the LAD or LCX.
9. Extreme angulation (≥ 90 °) or excessive tortuosity (≥ two 45° angles) proximal to or within the lesion.
10. Heavy calcification proximal to or within the target lesion.
11. Target vessel contains thrombus as indicated in the angiographic images.
12. Target lesion has a high probability that a procedure other than pre-dilatation and stenting will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon).
13. Target vessel is previously treated with any type of PCI (e.g. balloon angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure.
14. Non-target vessel is previously treated with any type of PCI < 90 days prior to the index procedure.
15. Additional clinically significant lesion(s) (e.g. %DS ≥ 50%) in a target vessel or side branch for which PCI may be required < 90 days after the index procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Core size registry (CSR); Core size indicates the range of diameters of the stents used.	Device: Core size Xience Prime; Core size includes a range of stent sizes.
Experimental: Long lesion registry (LLR); Use of long lesion stents.	Device: Xience Prime Long Lesion (LL); Long lesion stent sizes include a range of sizes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure (TLF)	The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.	1 year
Target Lesion Failure (TLF)	The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.	2 years
Target Lesion Failure (TLF)	The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Time	Procedure time is defined as time between insertion and withdrawal of guide catheter.	From insertion to withdrawal of guide catheter
Device Success (Lesion Basis)	Device success is defined as achievement of a final in-stent residual diameter stenosis of < 50% (by QCA).	From the start of index procedure to end of index procedure
Procedural Success (Subject Basis)	Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA). Per Protocol.	From the start of index procedure to end of index procedure
All Death (Cardiac, Vascular, Non-cardiovascular)		In-hospital is less than or equal to 7 days post index procedure
All Death (Cardiac, Vascular, Non-cardiovascular)		30 days
All Death (Cardiac, Vascular, Non-cardiovascular)		180 days
All Death (Cardiac, Vascular, Non-cardiovascular)		1 year
All Death (Cardiac, Vascular, Non-cardiovascular)		2 years
All Death (Cardiac, Vascular, Non-cardiovascular)		3 years
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)	Per Protocol	In-hospital is defined as hospitalization less than or equal to 7 days post index procedure.
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)	Per Protocol	30 days
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)	Per Protocol	180 days
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)	Per Protocol	1 year
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)	Per Protocol	2 years
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)	Per Protocol	3 years
Non-target Vessel MI (Q-wave, Non Q-wave)	Per Protocol	In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Non-target Vessel MI (Q-wave, Non Q-wave)	Per Protocol	30 days
Non-target Vessel MI (Q-wave, Non Q-wave)	Per Protocol	180 days
Non-target Vessel MI (Q-wave, Non Q-wave)	Per Protocol	1 year
Non-target Vessel MI (Q-wave, Non Q-wave)	Per Protocol	2 years
Non-target Vessel MI (Q-wave, Non Q-wave)	Per Protocol	3 years
Clinically Indicated-Target Lesion Revascularization		In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Clinically Indicated-Target Lesion Revascularization		30 days
Clinically Indicated-Target Lesion Revascularization		180 days
Clinically Indicated-Target Lesion Revascularization		1 year
Clinically Indicated-Target Lesion Revascularization		2 years
Clinically Indicated-Target Lesion Revascularization		3 years
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)		In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)		30 days
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)		180 days
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)		1 year
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)		2 years
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)		3 years
All TLR (CI and Non-CI)		In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
All TLR (CI and Non-CI)		30 days
All TLR (CI and Non-CI)		180 days
All TLR (CI and Non-CI)		1 year
All TLR (CI and Non-CI)		2 years
All TLR (CI and Non-CI)		3 years
All TVR (CI and Non-CI)		In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
All TVR (CI and Non-CI)		30 days
All TVR (CI and Non-CI)		180 days
All TVR (CI and Non-CI)		1 year
All TVR (CI and Non-CI)		2 years
All TVR (CI and Non-CI)		3 years
All Coronary Revascularization (TVR and Non-TVR)		In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
All Coronary Revascularization (TVR and Non-TVR)		30 days
All Coronary Revascularization (TVR and Non-TVR)		180 days
All Coronary Revascularization (TVR and Non-TVR)		1 year
All Coronary Revascularization (TVR and Non-TVR)		2 years
All Coronary Revascularization (TVR and Non-TVR)		3 years
Cardiac Death/All MI		In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Cardiac Death/ All MI	Per Protocol	30 days
Cardiac Death/All MI	Per Protocol	180 days
Cardiac Death/All MI	Per Protocol	1 year
Cardiac Death/All MI	Per Protocol	2 years
Cardiac Death/All MI	Per Protocol	3 years
Cardiac Death/ All MI/CI-TLR		in-hospital
Cardiac Death/ All MI/CI-TLR	Per Protocol	30 days
Cardiac Death/ All MI/CI-TLR	Per Protocol	180 days
Cardiac Death/ All MI/CI-TLR	Per Protocol	1 year
Cardiac Death/ All MI/CI-TLR	Per Protocol	2 years
Cardiac Death/ All MI/CI-TLR	Per Protocol	3 years
All Death/All MI/All Coronary Revascularization	Per Protocol	In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
All Death/All MI/All Coronary Revascularization	Per Protocol	30 days
All Death/All MI/All Coronary Revascularization	Per Protocol	180 days
All Death/All MI/All Coronary Revascularization	Per Protocol	1 year
All Death/All MI/All Coronary Revascularization	Per Protocol	2 years
All Death/All MI/All Coronary Revascularization	Per Protocol	3 years
Stent Thrombosis	Per protocol and per Academic Research Consortium (ARC, definite/probable)	Acute (≤1 day)
Stent Thrombosis	Per protocol and per ARC	Subacute (>1 - 30 days)
Stent Thrombosis	Per protocol and per ARC	Acute/Subacute (0 - 30 days)
Stent Thrombosis	Per protocol and per ARC	Late (31 - 393 days)
Stent Thrombosis	Per protocol	Late (31 - 758 days)
Stent Thrombosis	Per ARC, definite and probable	Very Late (394 - 758 days)
Stent Thrombosis	Per protocol	Late (31 - 1123 days)
Stent Thrombosis	Per ARC, definite and probable	Very Late (394 - 1123 days)
Stent Thrombosis	Per protocol and per ARC	Overall (0-393 days)
Stent Thrombosis	Per protocol	Overall (0-758 days)
Stent Thrombosis	Per ARC, definite and probable	Overall (0-758 days)
Stent Thrombosis	Per protocol	Overall (0 - 1123 days)
Stent Thrombosis	Per ARC, definite and probable	Overall (0 - 1123 days)

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Marco Costa, MD, PhD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: June 5, 2009
• First Submitted That Met QC Criteria: June 8, 2009
• First Posted (Estimate): June 9, 2009

Study Record Updates

• Last Update Posted (Estimate): June 8, 2015
• Last Update Submitted That Met QC Criteria: May 12, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Angioplasty; stents; drug eluting stents; Coronary Disease; Coronary Restenosis; myocardial ischemia; coronary artery stenosis; Long lesion
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia; Coronary Stenosis; Coronary Restenosis
• Other Study ID Numbers: 06-373