ELUTES II - In Stent ELUTES Study

Cook Group Incorporated1 个研究点分布在 1 个国家目标入组 124 人开始时间: 2002年4月最近更新: 2012年2月1日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Cook Group Incorporated
入组人数: 124
试验地点: 1
主要终点: Angiographic target vessel failure (TVF) at follow up

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial will compare the long term safety and effectiveness of the V Flex Plus PTX Drug Eluting coronary stent with conventional treatment for in-stent restenosis for coronary arteries.

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

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

•Patient has given informed consent
•Patient has target lesion in native coronary artery or coronary bypass graft
•Patient has in-stent restenosis >60%
•Patient has reference artery diameter 2.7-3.5
•Patient agrees to return for clinical assessment at 1, 6, 9, 12 and 24 months and for a treadmill test at 9 months and an angiogram at 9 months and 24 months.

排除标准

•Patient is less than 18 years of age
•Patient is pregnant or breast feeding
•Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
•Patient is simultaneously participating in another investigative interventional cardiovascular drug or device study.
•Patient has known hypersensitivity or contraindication to aspirin or stainless steel or a sensitivity to contrast agent.

结局指标

主要结局

Angiographic target vessel failure (TVF) at follow up

次要结局

Major adverse events
Target lesion revascularization

研究者

发起方

Cook Group Incorporated

申办方类型

Industry

研究点 (1)

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