NCT00766129Unknown3 期
Comparison of Safety and Efficacy of Drug Eluting Stents : TAXUS (Boston Scientific) vs. LUC-Chopin (Balton, Poland) Implanted Into Saphenous Vein Grafts. Study With Serial Intravascular Ultrasounds.
National Institute of Cardiology, Warsaw, Poland2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年2月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Neointima hyperplasia volume by Intravascular Ultrasound
研究概览
简要总结
Drug eluting stents significantly reduced the rate of in-stent restenosis in coronary arteries. There are several kinds of DES i.e. eluting the drug either from stable or biodegradable polymer. The type of the polymer may impact the clinical outcome. The aim of our study was to compare safety and efficacy of implantation of two different types of stents eluting paclitaxel from stable vs biodegradable polymer (TAXUS stent vs LUC-CHOPIN stent) into coronary artery by-pass graft.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atherosclerotic lesion in saphenous vein grafts causing angiographic stenosis ≥70%
- •Stable coronary artery disease or non ST segment elevation acute coronary syndrome
- •Reference segment diameter in range of 2.5-4.5mm
排除标准
- •Cardiogenic shock
- •Contraindications to prolonged dual antiplatelet therapy
- •Female of child birth potential unless on effective contraception
- •Other medical condition that may limit survival
结局指标
主要结局
Neointima hyperplasia volume by Intravascular Ultrasound
时间窗: 9 months
次要结局
- All cause mortality(5 years)
- Cardiovascular mortality(5 years)
- Target lesion revascularization(5 years)
- Angiographic late loss(9 months)
- Stent thrombosis(5 years)
研究者
研究点 (2)
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