The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)

Completed · Phase 3

Conditions studied: Coronary Artery Disease

In brief

The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

Key facts

Study ID: NCT01665053
Run by: Boston Scientific Corporation
People needed: 1684
Starts: 2012-11-01
Expected to finish: 2018-12-22
Last updated by the study team: 2019-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject must be at least 18 years of age
Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
For subjects less than 20 years of age enrolled at a Japanese site, the subject and the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed
Subject is eligible for percutaneous coronary intervention (PCI)
Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
Subject is willing to comply with all protocol-required follow-up evaluation
Angiographic Inclusion Criteria (visual estimate):
Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm
Target lesion(s) length must be ≤34 mm (by visual estimate)
Target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in Myocardial Infarction (TIMI) flow >1 and one of the following: stenosis ≥70%, abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers prior to the procedure
Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
The first lesion treated must be successfully predilated/pretreated

You may not qualify if…

Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
Subject has received an organ transplant or is on a waiting list for an organ transplant
Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
Planned PCI (including staged procedures) or CABG after the index procedure
Subject previously treated at any time with intravascular brachytherapy
_ Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)
Subject has one of the following (as assessed prior to the index procedure):
Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months
Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
Planned procedure that may cause non-compliance with the protocol or confound data interpretation
Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome
Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3
Subject has a white blood cell (WBC) count < 3,000 cells/mm3
Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)
Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
Subject has severe symptomatic heart failure (i.e., NYHA class IV)
Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)
Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)
Angiographic Exclusion Criteria (visual estimate):

Where it is running

Banner Good Samaritan Medical Center — Phoenix, Arizona, United States
Arkansas Heart Hospital — Little Rock, Arkansas, United States
Bakersfield Memorial Hospital — Bakersfield, California, United States
University of California Davis Health System — Sacramento, California, United States
Sutter Memorial Hospital — Sacramento, California, United States
Alvarado Hospital Medical Center — San Diego, California, United States
North Colorado Medical Center — Greeley, Colorado, United States
South Denver Cardiology Associates, PC — Littleton, Colorado, United States
Washington Hospital Center — Washington D.C., District of Columbia, United States
Morton Plant Mease Healthcare — Clearwater, Florida, United States
University of Miami McKnight Brain Institute — Miami, Florida, United States
MediQuest — Ocala, Florida, United States
Florida Hospital Medical Center — Orlando, Florida, United States
Tallahassee Research Institute, Inc. — Tallahassee, Florida, United States
Medical Center of Central Georgia — Macon, Georgia, United States
Wellstar Health Systems — Marietta, Georgia, United States
Kaiser Foundation Hospital — Honolulu, Hawaii, United States
Kootenai Medical Center — Coeur d'Alene, Idaho, United States
Prairie Cardiovascular Consultants, Ltd. — Springfield, Illinois, United States
Northern Indiana Research Alliance — Fort Wayne, Indiana, United States
St. Vincent's Medical Group, Inc. — Indianapolis, Indiana, United States
Genesis Medical Center — Davenport, Iowa, United States
Mercy Hospital Medical Center — Des Moines, Iowa, United States
Kings Daughters Medical Center — Ashland, Kentucky, United States
Baptist Medical Center - Princeton — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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