NCT00232856已完成4 期
A Multi-Center, Non-Randomised Study of the CYPHER™ Sirolimus-Eluting Stent in the Treatment of Patient With an in-Stent Restenotic Native Coronary Artery Lesion
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 4
- 主要终点
- angiographic in-lesion late loss
研究概览
简要总结
The main objective of this study is to assess the safety and effectiveness of the Cypher™ sirolimus-eluting stent in reducing angiographic in-lesion late loss in patients with an in-stent restenotic native coronary artery lesion.
详细描述
This is a multicenter (11 sites), non-randomized study. Patients who meet the eligibility criteria will be treated with the Cypher™ sirolimus-eluting stent. All patients will have a repeat angiography at six months post-procedure and will be additionally followed clinically at 1, 6 and 9 months and up to 3 years. The results of this study will be compared with the outcome of the GAMMA I / II as the historical control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 否
入选标准
- •The patient has an in-stent restenosis of ≥ 60% and < 100% (by QCA online of the MLD compared to the distal reference diameter) in a native coronary artery.
- •The study target lesion can not be located in a vessel containing another lesion requiring treatment. Lesions located in other vessels may be treated with percutaneous revascularization at the time of the procedure, BUT they must be successfully treated prior to the treatment of the study target lesion.
排除标准
- •Unprotected left main coronary disease with ≥ 50% stenosis;
- •Patient previously treated with brachytherapy in any coronary vessel.
- •Target lesion involves bifurcation including a side branch >2.5mm in diameter.
- •The patient sustained a recent (<72 hours) myocardial infarction defined as a serum CK 2x the upper limit of normal and elevated MB or abnormal lab values.
结局指标
主要结局
angiographic in-lesion late loss
时间窗: 6 months post-procedure
次要结局
- in-stent mean percent diameter stenosis (%DS)(6-months post-procedure)
- i-stent late loss (LL)(6 months post-procedure)
- in-lesion binary restenosis(6-months post-procedure)
- Target Vessel Revascularization (TVR)(9-months post-procedure)
- Target Vessel Failure (TVF) defined as any revascularization of the index vessel or myocardial infarction or death that cannot be clearly attributed to a vessel other than the index vessel(9 months post-procedure)
- Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization in-hospital(1, 6, 9 months and, 2 and 3 years post-procedure)
- occurrence of bleeding(1, 6, 9 months and, 2 and 3 years post-procedure)
研究者
研究点 (4)
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