Trial to Assess the Use of the Cypher TM Stent in Acute Myocardial Infarction Treated With Balloon Angioplasty
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 715
- 试验地点
- 2
- 主要终点
- Composite of target vessel failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vesselpost-procedure.
研究概览
简要总结
The main objective of this study is to assess the effectiveness and safety of the CYPHER™ (CYPHER SELECT™) (Sirolimus-eluting) stent in reducing the occurrence of a composite endpoint of target vessel failure (TVF) in subjects treated for acute myocardial infarction as compared to a bare metal stent.
详细描述
This is an international, multicenter (up to 52 sites), randomized, single-blind study in patients with an acute myocardial infarction treated with the CYPHER™ (Sirolimus-eluting) stent as compared to the bare stents.
Patients with de novo native coronary artery lesions will be treated with the CYPHER™ (Sirolimus-eluting) stent or a bare stent. Subjects will be followed at 30 days, 6 months and at 1, 3, 4 and 5 years post-procedure. 200 subjects will have an angiographic follow-up at 8 months.
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
- •Have prolonged, continuous (lasting at least 20 minutes) chest pain despite administration of nitrates and onset within 12 hours of randomization, and one of the following:
- •ST segment elevation >=1mm in standard leads and >=2mm in 2 or more contiguous precordial leads with reciprocal ST depression
- •New or presumably new left bundle branch block (LBBB)
- •The culprit lesion must be identified on a de novo native coronary artery and an emergency angioplasty must be possible. The culprit site must be visualized before the stent implantation;
排除标准
- •Killip class > 2 upon arrival to the cath-lab;
- •Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff;
- •Evidence of massive thrombus in the infarct related artery distally to the culprit lesion;
- •Documented left ventricular ejection fraction <=30%;
- •Target lesion is located in an arterial or venous by-pass graft;
- •ECG documented evidence of prior myocardial infarction;
- •Patient who received thrombolytic therapy for the current AMI before enrollment in this study.
研究组 & 干预措施
1
Cypher Sirolimus-eluting Coronary Stent
干预措施: drug-eluting stent (Device)
2
Bare-metal stent
干预措施: bare-metal stent (Device)
结局指标
主要结局
Composite of target vessel failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vesselpost-procedure.
时间窗: 1 and 6 months and at 1, 3, 4, and 5 years post-procedure.
次要结局
- recurrence of myocardial infarction(1, 3, 4 and 5 years post-procedure)
- revascularization of the target vessel (TVR)(1, 3, 4 and 5 years post-procedure)
- recurrence of ischemia(1, 3, 4 and 5 years post-procedure)
- cardiac death(1, 3, 4 and 5 years post-procedure)