NCT00739401已完成不适用
Endologix Powerlink® Suprarenal Proximal Cuff
Endologix16 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2006年5月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 16
- 主要终点
- Number of Subjects With Proximal Type I Endoleak
研究概览
简要总结
The use of a suprarenal extension device during the index AAA procedure to accommodate the patient's anatomy and to prevent or repair leakage.
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
- •18 years old
- •Informed consent understood and signed
- •Will comply with post-treatment follow-up requirements up to 5 years
- •Candidate for Powerlink Infrarenal Bifurcated Graft
排除标准
- •Life expectancy < 2 years
- •Participating in another clinical research study
- •Pregnant or lactating women
- •Patient has other medical or psychiatric problems, which in the opinion of the Investigator, precludes them from participating in the Study
- •Creatinine level > 1.7mg/dl
- •Renal transplant patient
- •Patient with > 75% renal artery stenosis and not eligible for PTA/stent intervention prior to suprarenal device fixation
结局指标
主要结局
Number of Subjects With Proximal Type I Endoleak
时间窗: Within 30 Days
The primary study endpoint is defined as the incidence of type I proximal endoleak at 30 days post-treatment.
次要结局
- Endoleak(30 days)
- Number of Participants With Stent Graft Integrity and Performance(30 days)
- Number of Subjects With Major Adverse Events(Within 30 days)
- Renal Function(30 days)
- Aneurysm Morphology Changes(30 days)
研究者
研究点 (16)
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