NCT03190473终止不适用
The OPTIMIZE Trial to Assess the Procedural and Clinical Value of the Svelte IDS and RX Sirolimus Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions in a Randomized Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,630
- 试验地点
- 124
- 主要终点
- Target Lesion Failure (TLF)
研究概览
简要总结
Indication for use: "The Svelte DES is indicated for improving coronary luminal diameter in patients with symptomatic heart disease, including patients with non-ST elevation MI due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length with a reference vessel diameter of 2.25 mm - 4.00 mm
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is an eligible candidate 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 has up to 3 de novo target lesions in up to 2 native coronary artery vessels, with no more than 2 lesions in a single vessel, each meeting the angiographic criteria and none of the exclusion criteria.
- •Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥ 2.25 mm and ≤ 4.00 mm;
排除标准
- •The subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina;
- •The subject's target lesion(s) is located in the left main artery;
- •The subject's 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;
- •The subject's target lesion(s) is located within a saphenous vein graft or arterial graft;
- •The subject's target lesion(s) will be accessed via a saphenous vein graft or arterial graft;
结局指标
主要结局
Target Lesion Failure (TLF)
时间窗: 12 months
次要结局
- Stent Thrombosis(6 and 12 months and annually through 5 years follow-up)
- Target Vessel Failure (TVF)(6 and 12 months, and annually through 5 years)
- Major Adverse Cardiac Event (MACE)(6 and 12 months and annually through 5 years follow-up)
研究者
研究点 (124)
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