A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rate of Technical Success Through the One Month Follow up.
研究概览
简要总结
This study is a multi-center prospective, open label, non-randomized investigation of INCRAFT™ in subjects with abdominal aortic aneurysms.
The study will enroll up to 60 subjects in up to 7 sites in Germany and Italy.
详细描述
This study is a multi-center prospective, open label, non-randomized investigation of INCRAFT™ in subjects with abdominal aortic aneurysms. The study will enroll up to 60 subjects at 7 sites in Germany and Italy. All treated subjects will be evaluated at 1 month, 3 months (if applicable), 6 and 12 months, and annually for a total of 5 years post-procedure. An interim analysis will be conducted after the 25th enrolled subject reaches the 30-day follow up visit
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Rate of Technical Success Through the One Month Follow up.
时间窗: From procedure to one month follow up
Technical success is defined as the successful deployment of the stent-graft to the desired location in the absence of Types I, III or IV endoleaks at the conclusion of the procedure and through the one month follow up.
Rate of Primary Safety Endpoint Within 1 Month Post-procedure.
时间窗: One month follow-up
Primary safety is defined by the absence of Types I, III or IV endoleaks and device and/or procedural related major adverse events within 1 month post-procedure. Major adverse events include death, MI, stroke and renal failure.
次要结局
- The Percentage of Participants With Stent Graft Explant at 30 Days and Annually Through 5 Years Post - Procedure.(From day 1 through year 5 post-procedure)
- The Cumulative Percentage of Participants With Major Adverse Events at Annually Through 5 Years Post - Procedure.(From day 1 through year 5 post-procedure)
- The Percentage of Participants With Endoleg Patency at 30 Days and Annually Through 5 Years Post - Procedure.(From day 1 through year 5 post-procedure)
- Percentage of Participants With Incidence of Stent-graft Migration Annually Through 5 Years Post - Procedure.(Day 30 through year 5 post-procedure)
- The Percentage of Participants With Thrombosis at 30 Days and Annually Through 5 Years Post - Procedure.(From day 1 through year 5 post-procedure)
- Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure.(Day 30 through year 5 post-procedure)
- The Percentage of Participants With Endoleaks at Annually Through 5 Years Post - Procedure.(From day 1 through year 5 post-procedure)
- The Percentage of Participants With Stent-graft Fractures at 30 Days and Annually Through 5 Years Post - Procedure.(From day 1 through year 5 post-procedure)