NCT01268371Unknown4 期
Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents
Ajou University School of Medicine26 个研究点 分布在 1 个国家目标入组 1,462 人开始时间: 2010年12月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,462
- 试验地点
- 26
- 主要终点
- The Number of Participants with Majour Adverse Cardiac Events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis
研究概览
简要总结
To compare the safety and efficacy of coronary stenting with everolimus-eluting stent (Promus Element®) and biolimus-eluting stent with biodegradable polymer (Nobori®)
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Significant coronary artery stenosis (> 50% by visual estimate)
- •Stable angina, unstable angina, Non-ST elevation myocardial infarction (NSTEMI) and documented silent ischemia
- •Patients eligible for intracoronary stenting
- •age ≥ 20 years old
排除标准
- •ST segment elevation myocardial infarction (within 24 hours)
- •Low ejection fraction (< 25%)
- •Cardiogenic shock
- •History of bleeding diathesis or known coagulopathy
- •Limited life-expectancy (less than 1 year) due to combined serious disease
- •Contraindication to heparin, sirolimus, everolimus and biolimus
- •Contraindication to aspirin and clopidogrel
- •Pregnancy
结局指标
主要结局
The Number of Participants with Majour Adverse Cardiac Events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis
时间窗: 1 year after index procedure
次要结局
- In-stent and in-segment late loss at 1 year angiographic follow-up(1 year after index procedure)
- The number of participants with majour adverse cardiac events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis(2 years after index procedure)
- Death (all-cause and cardiac)(1 to 2 years after index procedure)
- Myocardial infarction (Q wave and non-Q wave)(1 to 2 years after index procedure)
- Target vessel revascularization (ischemia- and clinically-driven)(1 to 2 years after index procedure)
- Target lesion revascularization (ischemia- and clinically-driven)(1 to 2 years after index procedure)
- Stent thrombosis(1 to 2 years after index procedure)
- In-stent and in-segment restenosis at 1 year angiographic follow-up(1 year after index procedure)
- Incidence and angiographic pattern of restenosis at 1 year angiographic follow-up(1 year after index procedure)
- The incidence of Procedural success(index procedure (day 0))
- The number of participants with death and myocardial infarction(1 to 2 years after index procedure)
研究者
Seung-Jea Tahk
Dr.
Ajou University School of Medicine
研究点 (26)
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