EVOLVE II QCA: A Prospective, Multicenter Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)
- Conditions
- Atherosclerotic Lesion(s)
- Interventions
- Device: SYNERGY
- Registration Number
- NCT01787799
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The purpose of this study is to evaluate 9 month angiographic and intravascular ultrasound (IVUS) data for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) in 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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 pre-dilated/pretreated
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Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
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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
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Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
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Planned PCI (including staged procedures) or CABG after the index procedure
-
Subject previously treated at any time with intravascular brachytherapy
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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 (clopidogrel, ticlopidine, prasugrel, or ticagrelor), or aspirin)
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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
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Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome
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Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3
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Subject has a white blood cell (WBC) count < 3,000 cells/mm3
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Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
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Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)
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Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
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Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
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Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
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Subject has severe symptomatic heart failure (i.e., New York Heart Association (NYHA) class IV)
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Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
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Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
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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)
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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)
Planned treatment of more than 3 lesions
- Planned treatment of lesions in more than 2 major epicardial vessels
- Planned treatment of a single lesion with more than 1 stent
- Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate)
- Target lesion(s) is located in the left main
- Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate.
- Target lesion(s) is located within a saphenous vein graft or an arterial graft
- Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
- Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
- Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
- Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent
- Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
- Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure
- Thrombus, or possible thrombus, present in the target vessel (by visual estimate)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SYNERGY Stent System SYNERGY SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)
- Primary Outcome Measures
Name Time Method In-stent Late Loss 9 month In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
The Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
St Vincent's Hospital Melbourne
🇦🇺Fitzroy, Victoria, Australia
Fremantle Hospital
🇦🇺Fremantle, Western Australia, Australia
Shonan Kamakura General Hospital
🇯🇵Kamakura-shi, Kanagawa, Japan
Mercy Angiography Unit, Ltd.
🇳🇿Auckland, New Zealand
Auckland City Hospital
🇳🇿Auckland, New Zealand
Ascot Angiography Ltd
🇳🇿Auckland, New Zealand
Middlemore Hospital
🇳🇿Auckland, New Zealand
North Shore Hospital
🇳🇿Auckland, New Zealand
Christchurch Hospital NZ
🇳🇿Christchurch, New Zealand
National University Hospital
🇸🇬Singapore, Singapore
Monash Medical Centre-Clayton Campus
🇦🇺Clayton, Victoria, Australia
National Heart Centre
🇸🇬Singapore, Singapore