Multicenter, Randomized, Non-inferiority Study of Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 570
- 试验地点
- 1
- 主要终点
- in-stent late lumen loss at 9 months' angiographic follow-up
研究概览
简要总结
Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating patients with coronary artery disease (CAD). The efficacy and safety of Excel SES (JW Medical, Shandong, China, MA) with biodegradable polymer has been proved by several clinical trials. Here the investigators design a prospective, multicenter, randomized clinical study in purpose of identifying the non-inferiority in the efficacy and safety in treating CAD patients by Firebird 2 SES (Microport, Shanghai) with durable polymer, comparing with Excel SES.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •male or un-pregnant female
- •stenosis > 70% in one of major the epicardial coronary arteries
- •no contra-indications of stent implantation
- •singed the informed consent
排除标准
- •acute myocardial infarction within one week
- •have contra-indications of stent implantation or can not tolerate dual antiplatelet therapy
- •no history of stent implantation within last one-year
- •received other brand coronary stent during index procedure
- •with no achievement of informed consent
结局指标
主要结局
in-stent late lumen loss at 9 months' angiographic follow-up
时间窗: 9 months
patients are planned to receive angiographic follow-up at 9 months after index procedure, and in-stent late lumen loss will be analyzed
次要结局
- target vessel failure(2 years after index procedure)