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临床试验/NCT01605721
NCT01605721Unknown4 期

Efficacy and Safety of Xience in Coronary arEry Disease aLL-comers After stENTing Using the PRIME Platform (EXCELLENT-PRIME Registry)

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
4 期
入组人数
2,000
试验地点
1
主要终点
Target Lesion Failure (TLF) rate at 12 months

研究概览

简要总结

Objectives:

  1. To evaluate the safety and long-term effectiveness of coronary stenting with the XIENCE PRIMETM in a cohort of "real world" patients and lesion subsets.
  2. To determine clinical device and procedural success during commercial use of XIENCE PRIMETM coronary stent

Study population : Approximately consecutive 2000 patients treated with XIENCE PRIMETM

Study period

  • Patient enrollment: 2011.05 ~ 2012.04
  • End of follow-up period: 2015. 02 (3 years of follow-up)

Primary endpoint

: Target Lesion Failure (TLF) rate at 12 months

Secondary endpoint:

  • In-stent & In-segment Late Loss at 9 months
  • Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late)
  • Target Vessel Failure at 12 months (composite of cardiac death, MI, and TVR)
  • Any death, cardiac death, MI, TLR, TVR at 30 days, 9months, 1 year, 3 years
  • Composite rate of cardiac death and any MI up to 3 years
  • Composite rate of all death and any MI up to 3 years
  • Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization up to 3 years
  • Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years
  • Procedural success up to 1 day
  • Angiographic success up to 1 day

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Target Lesion Failure (TLF) rate at 12 months

时间窗: 12 months

次要结局

  • angiographic success up to 1 day(1 day)
  • In-stent & In-segment Late Loss at 9 months(9 months)
  • Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late)(24 hours, 30 days, up to 3 years)
  • Any death, cardiac death, MI, TLR, TVR at 30 days, 9 months, 1 year, 3 years(30 days, 9 months, 1 year, up to 3 years)
  • Composite rate of cardiac death and any MI up to 3 years(up to 3 years)
  • Composite rate of all death and any MI up to 3 years(up to 3 years)
  • Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization up to 3 years(up to 3 years)
  • Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years(up to 3 years)
  • procedural success up to 1 day(1 day)

研究者

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

Hyo-Soo Kim

MD PhD

Seoul National University Hospital

研究点 (1)

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