A Prospective Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGYTM Stent System) for the Treatment of Atherosclerotic Lesion(s)
- Conditions
- Symptomatic coronary artery disease or documented silent ischemia10011082
- Registration Number
- NL-OMON39360
- Lead Sponsor
- Boston Scientific International S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Clinical Inclusion criteria
CI1. Subject must be at least 18 years of age
CI2. 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
CI3. 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
CI4. Subject is eligible for percutaneous coronary intervention (PCI)
CI5. Subject has symptomatic coronary artery disease or documented silent ischemia
CI6. Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
CI7. Subject is willing to comply with all protocol-required follow-up evaluation;Angiographic Inclusion Criteria (visual estimate)
AI1. 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
AI2. Target lesion(s) length must be *34 mm (by visual estimate)
AI3. Target lesion(s) must have visually estimated stenosis *50% and <100% with thrombolysis in Myocardial Infarction (TIMI) flow >1
AI4. Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
AI5. The first lesion treated must be successfully pre-dilated
Note: Successful predilatation refers to dilatation with a balloon catheter of appropriate length, diameter, and placement to cover the lesion and inflated with enough pressure to dilate said lesion with no greater than 50% residual stenosis and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C.
Clinical Exclusion Criteria
CE1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
CE2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
CE3. Subject has received an organ transplant or is on a waiting list for an organ transplant
CE4. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
CE5. Planned PCI or CABG after the index procedure
CE6. Subject has a known allergy to 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) and contrast (that cannot be adequately premedicated)
CE7. Subject has a known condition(s) of the following (as assessed from the time of screening through the day of index procedure):
o Other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 24 months
o Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
o Planned procedure that may cause non-compliance with the protocol or confound data interpretation
CE8. Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
CE9. Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
CE10. 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)
CE11. 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)
AE1. Planned treatment of more than 3 lesions
AE2. Planned treatment of lesions in more than 2 major epicardial vessels
AE3. Planned treatment of a single lesion with more than 1 stent
AE4. Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate)
AE5. Target lesion(s) is located in the left main
AE6. Target lesion(s) is located within a saphenous vein graft or an arterial graft
AE7. Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
AE8. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
AE9. Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
AE10. Target lesion(s) is restenotic from a previous stent implantation
AE11. Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* The primary endpoint for the RCT and the Diabetes subtrial is the 12-month<br /><br>target lesion failure (TLF) rate, defined as any ischemia-driven<br /><br>revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave<br /><br>and non*Q-wave) related to the target vessel, or cardiac death.<br /><br>* There is no primary endpoint for the PK subtrial as it is an observational<br /><br>trial.</p><br>
- Secondary Outcome Measures
Name Time Method