NCT00739401已完成不适用
Endologix Powerlink® Suprarenal Proximal Cuff
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Endologix
- 入组人数
- 44
- 试验地点
- 8
- 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
研究组 & 干预措施
1
Experimental
Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension.
干预措施: Suprarenal Proximal Cuff Extension (Device)
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
- Aneurysm Morphology Changes(30 days)
- 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)
研究者
研究点 (8)
Loading locations...
相似试验
已完成
不适用
Apollo Overstitch, a Treat and Resect ModelColon Benign TumorColon Malignant TumorNCT01307813University Hospitals Cleveland Medical Center4
已完成
不适用
Modified Uterosacral Ligament Suspension in Vaginal HysterectomyVault Prolapse, VaginalModified Extraperitoneal Uterosacral Ligament SuspensionNCT03832543Kanuni Sultan Suleyman Training and Research Hospital40
已完成
2 期
Perineural local anaesthetic catheter after major lower limb amputation feasibility trialMajor lower limb amputationCirculatory SystemISRCTN85710690Aneurin Bevan University Health Board50
Unknown
2 期
Abdominal Aortic/Aorto-Iliac Aneurysm Endoluminal Graft StudyAortic AneurysmNCT00549354Arizona Heart Institute34
已完成
不适用
The thick peripheral venous cannulation adapting Seldinger's technique: a manikin studyManikinJPRN-UMIN000017670Shinshu University20