NCT01328730撤回4 期
Post-marketing Study Comparing the Efficacy and Safety of Firebird 2 Versus Cypher Sirolimus-eluting Stents in Treating Patients With Coronary Artery Disease in China
Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2011年4月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 430
- 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 Cypher SES (Cordis, MA) has been proved by several randomized 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), comparing with Cypher 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-preganant 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
Late luminal loss was defined as the difference between the minimal luminal diameter immediately after the placement of the stent and the minimal luminal diameter at 9 months
次要结局
- target vessel failure(1, and 2 years after index procedure)
研究者
研究点 (1)
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