Study Assessing Safety and Effectiveness of Perivisceral Aortic Aneurysm Treatment With the Zenith® Fenestrated AAA Endovascular Graft and the Zenith® p-Branch® and the Effects on Organ and Extremity Perfusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Technical Success:
研究概览
简要总结
The Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic 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 aneurysm > 5.0 cm or 2 times the normal aortic diameter
- •Abdominal aortic aneurysm with history of growth > 0.5 cm in 6 months
- •Penetrating juxtarenal aortic ulcer > 10 mm in depth and 20 mm in diameter
排除标准
- •Age < 18 years
- •Life expectancy < 2 years
- •Pregnant or breast feeding
- •Inability or refusal to give informed consent
- •Unwilling or unable to comply with the follow-up schedule
- •Additional medical restrictions as specified in the Clinical Investigation Plan
- •Additional anatomical restrictions as specified in the Clinical Investigation Plan
结局指标
主要结局
Technical Success:
时间窗: Immediately post graft deployment
Successful access of the aneurysm site and deployment of the Zenith® Fenestrated AAA Endovascular Graft or the Zenith® p-Branch™ in the intended location. The endovascular graft and all vessels targeted with fenestrations must be patent at the time of deployment completion as evidenced by intraoperative angiography
Procedural Success
时间窗: Within 30 days post graft deployment
Technical Success, with all of the following at post-procedure (within 30 days): * No type I or type III endoleaks; * No procedure related serious adverse events or major complications; * Patency of the endovascular graft and all vessels targeted with fenestrations as evidenced by CT scan, angiography or by duplex ultrasound in those patients experiencing renal failure or otherwise unable to undergo contrast enhanced CT scan.
Treatment Success
时间窗: 12 months
Procedural Success, with all of the following at 12 months: * No type I or type III endoleaks; * No serious adverse events or major complications; * No aneurysm enlargement greater than 0.5 cm; * Patency of the endovascular graft and all vessels targeted with fenestrations as evidenced by CT scan, angiography or by duplex ultrasound in those patients experiencing renal failure or otherwise unable to undergo contrast enhanced CT scan.
次要结局
未报告次要终点