NCT00920283已完成不适用
Randomized Comparison Between Two Cobalt-Chromium Balloon Expandable Stents for the Treatment of De Novo Coronary Artery Lesions
CID - Carbostent & Implantable Devices6 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2009年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 6
- 主要终点
- in-stent late lumen loss (LLL)
研究概览
简要总结
The COMPETE study is a prospective,randomized,two-arm multi-center clinical trial comparing two commercially available coronary stents: Chrono Carbostent Carbofilm™ Coated vs Driver/Micro-Driver Coronary Stent System. In this study, 204 subjects will be included (2:1 randomization Chrono:Driver/Micro Driver) in 6 Italian sites.
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
- •Patients with clinical evidence of ischemic heart disease;
- •No clinical and ECG changes suggestive of ongoing acute infarction;
- •De novo lesion > 50% and <100% diameter stenosis (DS) in native coronary vessels TIMI flow of >=
- •Reference diameter > 2.5 mm or < 4.0 mm;
- •Patients with a maximum of two coronary lesions to be treated with a maximum of 2 study stents;
排除标准
- •Lesion length > 30 mm;
- •Significant (>50%) stenosis proximal or distal to the target lesions that might impede run off;
- •Lesions located in saphenous vein graft;
- •Lesions located in unprotected left main;
- •Presence of > 40% stenosis in the left main;
- •Ostial lesion;
- •Lesion located in a bifurcation;
- •Target lesion with visible thrombus;
- •Chronic total occlusion;
- •Treatment of restenotic lesions;
- •Previous implantation of a stent (BMS/DES) in the target vessel.
研究组 & 干预措施
Driver, Cobalt Alloy Coronary Stent
Active Comparator
干预措施: Driver Cobalt Alloy Coronary Stent (Device)
Chrono Carbostent Carbofilm™ Coated Coronary Stent
Experimental
干预措施: Chrono Carbostent Carbofilm™ Coated Coronary Stent (Device)
结局指标
主要结局
in-stent late lumen loss (LLL)
时间窗: 180 days
次要结局
- Acute success (Device and Procedural success)(acute)
- Angiographic binary restenosis (diameter stenosis ≥50%)(180 days)
- Clinical Composite Endpoints: - Cardiac death/ MI - Cardiac death / Target vessel MI / (Clinically indicated) TLR* - All death / MI / all repeat revascularization** *Device oriented composite endpoint **Patient oriented composite endpoint(30 days, 180 days, 1 year)
- Stent Thrombosis(acute, 30 days, 180 days, 1 year)
研究者
研究点 (6)
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