跳至主要内容
临床试验/NCT01612819
NCT01612819终止不适用

Evaluation of Effectiveness and Safety of DXR(Previous Cilotax) Stent in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-CILOTAX)

Seung-Jung Park18 个研究点 分布在 1 个国家目标入组 451 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
451
试验地点
18
主要终点
composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)

研究概览

简要总结

Registry of cilotax stent(Dual drug eluting stent) implantation for CAD patients

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients with significant coronary artery disease and receiving Cilotax (dual drug eluting stent)
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site

排除标准

  • Patients with a mixture of other DESs
  • Terminal illness with life expectancy <1 year
  • Patients presented with cardiogenic shock

结局指标

主要结局

composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)

时间窗: at 12 months post procedure

次要结局

  • Death (all cause and cardiac)(12 months and yearly up to 5 years)
  • Myocardial Infarction(6 months)
  • Procedural success(at day 1)
  • Stent thrombosis(6 months)
  • Composite of death or MI(12 months and yearly upto 5 years)
  • Composite of cardiac death or MI(12 months and yearly up to 5 years)
  • Target Vessel Revascularization(6 months)
  • Target-lesion revascularization(12 months and yearly up to 5 years)

研究者

发起方
Seung-Jung Park
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Seung-Jung Park

MD, PhD

CardioVascular Research Foundation, Korea

研究点 (18)

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