Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With Coronary Artery Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Target Vessel Revascularization
研究概览
简要总结
Aim of the study is to compare the everolimus eluting stent and sirolimus eluting stent in all comers PCI eligible patients
详细描述
Compared with the currently available first-generation drug-eluting stents (DES), second-generation DES have been designed with the goal of improving safety and efficacy. Everolimus, a sirolimus analogue, is released from a open cell, thin-strut, cobalt-chromium frame. A significant reduction in cardiac events was noted in patients with the everolimus-eluting stent compared with those who had a paclitaxel-eluting stent. Sirolimus eluting stent was the first available drug eluting stent and is the most tested. Therefore the investigators compared the safety and efficacy of the everolimus-eluting and sirolimus eluting stents in unselected patients in real world practice.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with coronary artery disease eligible for percutaneous coronary intervention (PCI)
排除标准
- •Contraindication to dual antiplatelet therapy for 12 months
- •Known allergy to sirolimus or everolimus
- •Major surgical procedure planned within 1 month
- •History, symptoms, or findings suggestive of aortic dissection.
- •Participation in other trials
- •Pregnancy
结局指标
主要结局
Target Vessel Revascularization
时间窗: 2 year
Incidence of clinically driven target vessel revascularization at 2 year follow up
次要结局
- stent thrombosis(2 year)
- non fatal myocardial infarction(2 year)
- cardiac death(2 year)