NCT01400919已完成不适用
Protege® EverFlex™ and GPS™ Self-Expanding Iliac Study (DURABILITY™ Iliac)
Medtronic Endovascular1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2011年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Major Adverse Event Rate
研究概览
简要总结
The DURABILITY Iliac study is a prospective, multi-center, non-randomized study confirming the safety and effectiveness of stenting using the Protégé® EverFlex™ and Protégé® GPS™ Self-Expanding Stent Systems for the treatment of atherosclerotic lesions in the common and/or external iliac arteries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patient has claudication as defined by a Rutherford Clinical Category Score of 2, 3 or
- •Evidence of ≥ 50% stenosis, restenosis or occlusion of target lesion(s) located in the common iliac artery and/or external iliac artery.
- •Willing to comply with all follow-up evaluations at the specified times.
- •Provides written informed consent prior to enrollment in the study.
排除标准
- •Previous implantation of stent(s) in the target vessel.
- •Received endovascular treatment of the target lesion within six months prior to the index procedure.
- •Known hypersensitivity to contrast material that cannot be adequately pretreated.
- •Known hypersensitivity to nickel-titanium.
- •Life expectancy of less than 12 months
研究组 & 干预措施
Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
Experimental
The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
干预措施: Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System. (Device)
结局指标
主要结局
Major Adverse Event Rate
时间窗: 9 months
次要结局
未报告次要终点
研究者
研究点 (1)
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