China Made Sirolimus Eluting Stent for Treatment of Coronary Intermediate Lesion
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- target vessel failure
研究概览
简要总结
Sirolimus-eluting stent (SES) has been proven to improve outcomes in patients with significant coronary artery diseae(> 70% lumen diameter narrowing). But, acute coronary syndrome may occur in those with intermediate lesions(50%-70% lumen diameter narrowing), and the effect of SES in these patients remains unclear. Here the investigators hypothesize that application of China-made SES may improve the clinical outcomes in these setting.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-80 years old
- •both gender
- •native coronary lesion
- •narrowing 50-70%
- •vessel size 2.5-4.0 in diameter
排除标准
- •without informed consent,
- •ST elevation myocardial infarction within 7 days,
- •left main lesion,
- •by-pass graft,
- •restenosis
- •abnormal liver function before randomization,
- •active hepatitis or muscular disease,
- •impaired renal function with serum creatinine level > 3mg/dl ,
- •impaired left ventricular function with LVEF < 30%,
- •participate in other studies.
结局指标
主要结局
target vessel failure
时间窗: 12 months
defined as the occurrence of any of the following within 12 months after the index procedure: death from cardiac causes, Q-wave or non-Q-wave myocardial infarction, or revascularization of the target vessel (emergency or elective coronaryartery bypass grafting \[CABG\] or repeated percutaneous transluminal coronary angioplasty \[PTCA\]).
次要结局
- major adverse cardiac events(12 months)