NCT00960648已完成不适用
EXCELLENT (Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing) Registry
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,056
- 试验地点
- 36
- 主要终点
- Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)
研究概览
简要总结
The objective of this study is to evaluate the safety and long-term effectiveness of coronary stenting with the everolimus-eluting stent (EES) and to determine clinical device and procedural success during commercial use of EES in the real world.
The investigators will compare EES (Xience/Promus, prospective arm) with sirolimus-eluting stent (SES, Cypher, retrospective arm).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 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.
研究组 & 干预措施
Xience/Promus
Active prospective registration of patients receiving everolimus eluting stent
干预措施: Xience/Promus (Device)
Cypher
Retrospective historical controls that received sirolimus-eluting stent
干预措施: Cypher (Device)
结局指标
主要结局
Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)
时间窗: 12 months
次要结局
- In-stent & In-segment Late Loss(9 months)
- Stent Thrombosis(1 year)
- Target Vessel Failure (composite of cardiac death, MI, and TVR)(12 months)
- Any death, cardiac death, MI, TLR, TVR(1 year)
- Composite rate of cardiac death and any MI(1 year)
- Composite rate of all death and any MI(1 year)
- Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization(1 year)
- Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy(1 year)
- Clinical device and procedural success(During the health care facility stay)
研究者
Hyo-Soo Kim
Investigator
Seoul National University Hospital
研究点 (36)
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