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临床试验/NCT01268371
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

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

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Seung-Jea Tahk

Dr.

Ajou University School of Medicine

研究点 (26)

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