NCT02308839已完成不适用
Study of the GORE® EXCLUDER® Endoprosthesis in the Treatment of Infra-renal Abdominal Aortic Aneurysms
W.L.Gore & Associates1 个研究点 分布在 1 个国家目标入组 181 人开始时间: 2012年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 181
- 试验地点
- 1
- 主要终点
- Percentage of Participants Survived at 5 Years
研究概览
简要总结
This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® Excluder® Endoprosthesis in the treatment of infra-renal Abdominal Aortic Aneurysms (AAA).
详细描述
The use of abdominal aortic endoprostheses makes the treatment of infra-renal abdominal aortic aneurysms possible, with implantation via the femoral artery, thus avoiding a very invasive surgical procedure. The French National Authority for Health requires a 5-year follow-up as part of the renewal for reimbursement for these endoprostheses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Any patients requiring abdominal aortic stenting for the treatment of an unruptured infra-renal aortic abdominal aneurysm.
排除标准
- •Patients whose clinical follow-up is not possible, i.eg, patient who cannot return for control visits (e.g. patients living abroad).
结局指标
主要结局
Percentage of Participants Survived at 5 Years
时间窗: 5 years
Kaplan-Meier estimate of participant survival at 5 years
次要结局
- Percentage of Participants Free From Aneurysm Diameter Growth at 5 Years(5 years)
- Percentage of Participants Free From Surgical Conversion at Procedure(Index Procedure)
- Percentage of Participants Free From Migration at 5 Years(5 years)
- Percentage of Participants Free From Endoleak at 5 Years(5 years)
- Percentage of Participants Free From Aneurysm Related Mortality at 5 Years(5 years)
- Percentage of Participants Free From Endovascular or Surgical Re-intervention at 5 Years(5 years)
研究者
研究点 (1)
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