NCT00870038Unknown4 期
Early Re-Endothelialization Might Not be the Unique Solution to Prevent Restenosis. The EREMUS Study
Ospedale della Misericordia2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2010年12月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Late luminal loss between the three groups at 6 months angiographic follow up.
研究概览
简要总结
The investigators sought to discover which one of the following strategies is the safest for patients undergoing percutaneous coronary intervention: paclitaxel-coated balloon+Genous stent; Genous stent; drug eluting stent (paclitaxel).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable or unstable angina pectoris suitable to PCI of at least one coronary vessel
- •Age >18 years
排除标准
- •Recent (<72 hours) acute myocardial infarction
- •Creatinine clearance <40 ml/min
- •Allergy or hypersensitivity to at least two between: aspirin, clopidogrel, heparin, bivalirudin, paclitaxel, contrast media
- •Life expectancy <1 year
结局指标
主要结局
Late luminal loss between the three groups at 6 months angiographic follow up.
时间窗: 6 months
Percent of stent struts covered by endothelium at optical coherence tomography, during 6 months angiographic follow up.
时间窗: 6 months
次要结局
- Angiographic restenosis (6 months angiographic follow up).(6 months)
- Net adverse clinical events at 6 months (death, myocardial infarction, target lesion revascularization, bleedings as from Acuity scale).(6 months)
研究者
研究点 (2)
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