Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 50
- 主要终点
- Patients With Device Failures
研究概览
简要总结
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac, and 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, aortoiliac, and iliac aneurysms of appropriate size
- •Vessels suitable for endovascular access and aneurysm repair
排除标准
- •Less than 18 years of age
- •Inability or refusal to give informed consent
- •Disease considerations that would compromise patient safety or study outcomes
- •Unsuitable arterial anatomy
研究组 & 干预措施
1
Treatment with Endovascular Graft
干预措施: Zenith(R) Low Profile AAA Endovascular Graft (Device)
结局指标
主要结局
Patients With Device Failures
时间窗: 12-month
Device success at 12-month is defined as: Technical Success (successful access of the aneurysm site, deployment of the graft in the intended location, and patency of the graft at the time of deployment completion intra-operatively), and freedom from the following at 12 months: Type I or type III endoleaks requiring re-intervention, Aneurysm rupture or conversion to open surgical repair, and Aneurysm enlargement greater than 0.5 cm.
Patients With Major Adverse Events (MAE)
时间窗: 30-day
MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation.
次要结局
未报告次要终点