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临床试验/NCT02845804
NCT02845804Unknown不适用

Harmonizing Optimal Strategy for Treatment of Coronary Atherosclerotic Lesions- Registry-based Study on the Effect and Safety of Xience Xpedition™/Alpine™, Everolimus-eluting Stent for Coronary Atherosclerotic Lesions: HOST-Alpine Registry

Seoul National University Hospital20 个研究点 分布在 1 个国家目标入组 1,533 人开始时间: 2015年7月最近更新:
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适应症

试验速览

阶段
不适用
入组人数
1,533
试验地点
20
主要终点
Target lesion failure
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objectives of this study are

  1. To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™ stent
  2. To evaulate the long-term efficacy and safety of coronary stenting with the Xience Xpedition™/Alpine™ stent
  3. To compare the long-term efficacy and safety of coronary stenting between the Xience Xpedition™/Alpine ™ stent and other contemporary drug-eluting stents which had established their own registry

详细描述

Secondary endpoints of this study are

Stent thrombosis-24 hours(acute), 30 days(subacute), 1 year(late), every 1 year till 3 years(very-late) after index PCI

Target vessl failure

Composite rate of cardiac death and any MI, 3 years

Composite rate of all death and any MI

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •The patient agrees to participate in this study by signing the informed consent form.
  • •Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form

排除标准

  • •There are no exclusion criteria for this registry.

结局指标

主要结局

Target lesion failure

时间窗: 12 months

Composite of cardiac death, non-fatal target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)

次要结局

  • Target vessel failure(12 months)
  • Composite rate of cardiac death and myocardial infarction(12 months, 3 years)
  • Composite rate of all-cause death and any myocardial infarction(12 months, 3 years)
  • Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization(12 months, 3 years)
  • Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy(12 months, 3 years)
  • Clinical device and procedural success rate(intraoperative)
  • Stent thrombosis(within 24 hours, 1 - 30 days, 31 days - 1 year, after 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyo-Soo Kim

Professor

Seoul National University Hospital

研究点 (20)

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