NL-OMON39360已完成3 期
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) - EVOLVE II - Device study - Boston Scientific
Boston Scientific International S.A.0 个研究点目标入组 200 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
排除标准
- •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)
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