Evaluation of the Safety and Effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 28
- 主要终点
- Number of Participants With Treatment Success
研究概览
简要总结
The Zenith(R) Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac 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
- 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 aneurysms with diameter greater than or equal to 5 cm
排除标准
- •Proximal neck less than 4 mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
- •Renal artery stenosis greater than 50 percent
结局指标
主要结局
Number of Participants With Treatment Success
时间窗: 6 months
Technical success (successful access, deployment, and patency of the Fenestrated Graft, and patency of all vessels targeted by a fenestration intra-operatively), and freedom from the following: type I or type III endoleaks, AAA-related serious adverse events, AAA-related major complications, and aneurysm enlargement greater than 0.5 cm. A serious adverse event is defined as any occurrence of death, aneurysm rupture, or conversion to open surgical repair. A major complication is defined as any occurrence of Q-wave myocardial infarction, congestive heart failure, cardiac ischemia requiring intervention, renal failure requiring permanent dialysis, bowel obstruction, ischemia, or fistula, stroke with permanent deficit, or paralysis.
次要结局
未报告次要终点