NCT00615069已完成2 期
A Clinical Study Evaluating the Use of the GORE EXCLUDER® AAA Endoprosthesis - 31mm In the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms
W.L.Gore & Associates2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2006年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of the 31 mm GORE EXCLUDER® AAA Endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms
详细描述
The primary objective of this study was to estimate the safety of the 31 mm GORE EXCLUDER® AAA Endoprosthesis as compared to open surgical repair when used in the treatment of infrarenal abdominal aortic aneurysms. A secondary objective was to compare device performance of the original GORE EXCLUDER® AAA Endoprosthesis to the 31mm EXCLUDER when used in the 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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infrarenal AAA > or equal to 4.5 cm in diameter
- •Proximal infrarenal aortic neck length > or equal 15mm
- •Anatomy meets 31mm EXCLUDER specification criteria
- •Access vessel able to receive 20 Fr. introducer sheath
- •Life expectancy >2 years
- •Surgical candidate
- •ASA Class I, II, III, or IV
- •NYHA Class I, II, III
- •21 years of age or older
- •Male or infertile female
- •Ability to comply with protocol requirements including follow-up
- •Signed Informed Consent Form
排除标准
- •Mycotic or ruptured aneurysm
- •Participating in another investigational device or drug study within 1 year
- •Documented history of drug abuse within 6 months
- •Coexisting thoracic aortic aneurysm (50% larger than proximal aorta)
- •Myocardial infarction or cerebral vascular accident within 6 weeks
- •Pulmonary insufficiency requiring chronic home oxygen therapy or inability to ambulate due to pulmonary function
- •Renal insufficiency (Creatinine > 2.5 mg/dL) without dialysis
- •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 same position of the aorta or iliac arteries
- •Degenerative connective tissue disease, e.g., Marfans and Ehlers Danlos Syndrome
- •Proximal neck angulation > 60 degrees
- •Presence of significant thrombus at arterial implantation sites
结局指标
主要结局
Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year
时间窗: Treatment through 1 year post-procedure (365 days)
次要结局
- Number of Subjects With One or More of the Following Events: Type I Endoleak, Device Migration, Major Procedural Bleeding Complications(Treatment through 1 year window post-procedure (through end of 1 year window, 546 days))
研究者
研究点 (2)
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