Atherosclerotic Lesion(s) Clinical Trial
— EVOLVE II QCAOfficial title:
EVOLVE II QCA: A Prospective, Multicenter Trial to Assess the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) for the Treatment of Atherosclerotic Lesion(s)
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).
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | October 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 (clopidogrel, ticlopidine, prasugrel, or ticagrelor), 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., New York Heart Association (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) 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) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | The Prince Charles Hospital | Chermside | Queensland |
| Australia | Monash Medical Centre-Clayton Campus | Clayton | Victoria |
| Australia | St Vincent's Hospital Melbourne | Fitzroy | Victoria |
| Australia | Fremantle Hospital | Fremantle | Western Australia |
| Japan | Shonan Kamakura General Hospital | Kamakura-shi | Kanagawa |
| New Zealand | Ascot Angiography Ltd | Auckland | |
| New Zealand | Auckland City Hospital | Auckland | |
| New Zealand | Mercy Angiography Unit, Ltd. | Auckland | |
| New Zealand | Middlemore Hospital | Auckland | |
| New Zealand | North Shore Hospital | Auckland | |
| New Zealand | Christchurch Hospital NZ | Christchurch | |
| Singapore | National Heart Centre | Singapore | |
| Singapore | National University Hospital | Singapore |
| Lead Sponsor | Collaborator |
|---|---|
| Boston Scientific Corporation | Beth Israel Deaconess Medical Center, Medidata Solutions, Medstar Research Institute, Quintiles, Inc. |
Australia, Japan, New Zealand, Singapore,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | In-stent Late Loss | In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA) | 9 month | No |