NCT00593814已完成4 期
A Clinical Evaluation of the GORE EXCLUDER® Bifurcated Endoprosthesis - Low Permeability in the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms
W.L.Gore & Associates0 个研究点目标入组 139 人开始时间: 2005年6月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 主要终点
- Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure
研究概览
简要总结
The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic aneurysms.
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
- •Infrarenal Abdominal Aortic Aneurysms less than 4.5 cm in diameter
- •Anatomy meets EXCLUDER Bifurcated Endoprosthesis - Low Permeability specification criteria per Instructions for Use
- •Access vessel able to receive 18 French introducer sheath
- •Life expectancy > 2 years
- •Appropriate candidate for endovascular repair
- •Ability to comply with protocol requirements including follow-up
- •21 years of age or older, male or infertile female**
排除标准
- •Mycotic or ruptured aneurysm
- •Participating in another investigational device or drug study within one year
- •Documented history of drug abuse within six months
- •Myocardial infarction or cerebral vascular accident within six weeks
- •Pulmonary insufficiency requiring chronic home oxygen or inability to ambulate due to pulmonary function
- •Iliac anatomy that would require occlusion of both internal iliac arteries
- •Planned occlusion or reimplantation of significant mesenteric or renal arteries
- •Planned concomitant surgical procedure or previous major surgery within 30 days
- •Previous prosthesis placement in the aorta or iliac arteries
- •Degenerative connective tissue disease (e.g., Marfan's and Ehlers Danlos Syndrome)
结局指标
主要结局
Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure
时间窗: 2 years
次要结局
- Number of Subjects With Device Efficacy Events(2 years)
研究者
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