NCT01990950已完成不适用
Evaluation of the Long-term Safety and Performance of the Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Post-Approval Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 6
- 主要终点
- Treatment Success : AAA Related Mortality
研究概览
简要总结
This post-market study is approved by the US FDA to evaluate the long-term safety and performance of the Zenith® Fenestrated AAA Endovascular Graft.
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
- •abdominal aortic and aortoiliac aneursyms with a diameter greater than or equal to 5 cm
- •aortic or aortoiliac aneurysm with a history of growth greater than or equal to 0.5 cm per year, or clinical indication for AAA repair
排除标准
- •proximal neck less than 4mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
- •renal artery stenosis greater than 50 percent
研究组 & 干预措施
Zenith® Fenestrated AAA Endovascular Graft
Experimental
干预措施: Zenith® Fenestrated AAA Endovascular Graft (Device)
结局指标
主要结局
Treatment Success : AAA Related Mortality
时间窗: 5 years
patients treated with the Zenith® Fenestrated AAA Endovascular Graft will have a rate of aneurysm-related mortality at 5 years that meets a performance goal of 18% ,
次要结局
未报告次要终点
研究者
研究点 (6)
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