NCT00552994已完成不适用
A Danish Prospective Randomized Multicenter Comparison of the Xience V and the Cypher Select+ Stents in Unselective Patients With Diabetes Mellitus. An Intravascular Ultrasound Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- In stent neointimal hyperplasia
研究概览
简要总结
In stent neointimal hyperplasia may be less in the Cypher select plus stent compared to the Xience V stent in diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •All diabetic patients treated with one or more drug eluting stents in the coronary arteries at one of the 5 heart centres in Denmark (Gentofte, Rigshospitalet, Odense, Skejby, Aalborg) can be included in the study.
排除标准
- •The patient will not participate
- •The patient participates in other randomised stent studies
- •Expected survival < 1 year
- •Allergy to Aspirin, Clopidogrel or Ticlopidine
- •Allergy to Sirolimus or ABT-578
结局指标
主要结局
In stent neointimal hyperplasia
时间窗: Within 10 months
次要结局
- Peri-stent remodeling - Edge response to Cypher Select plus and Xience V stent - Malapposition - Angiographic late lumen loss(Within 10 months)
研究者
研究点 (2)
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