NCT03061825已完成不适用
Post-Market Study for Zenith Alpha™ Abdominal Endovascular Graft
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Device Success
研究概览
简要总结
The purpose of this study is to evaluate the clinical performance of the Zenith Alpha™ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.
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
- •A patient is considered eligible for inclusion in the study if the patient has an infrarenal abdominal aortic or aorto-iliac aneurysm and is intended to be treated with the Zenith Alpha™ Abdominal Endovascular Graft
排除标准
- •Life expectancy less than (<) 2 years
- •Inability or refusal to give informed consent by the patient or legally authorized representative
- •Unwilling or unable to comply with the study follow-up
结局指标
主要结局
Device Success
时间窗: 2 years
Technical success (successful introduction and deployment of the device in the absence of surgical conversion or mortality) plus freedom from the following: abdominal aneurysm rupture, conversion, Type I or III endoleak, graft limb occlusion and abdominal aneurysm size increase \> 5 mm.
次要结局
未报告次要终点
研究者
研究点 (5)
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