Clinical Study Plan for the Zenith® Low Profile AAA Endovascular Graft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 74
- 主要终点
- Number of Patients Without Major Adverse Events Within 30 Days
研究概览
简要总结
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic, aortoiliac, 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
- •Subject has at least one of the following
- •Aortic or aortoiliac aneurysm
- •Iliac aneurysm
- •Aneurysm with a history of growth
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
- •Pregnant of breastfeeding or planning on becoming pregnant with 60 months
- •Unwilling to comply with the follow-up schedule
结局指标
主要结局
Number of Patients Without Major Adverse Events Within 30 Days
时间窗: 30 days
Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation
Number of Patients With Device Success
时间窗: 12 months
Device success will be measured with none of the following: type I or III endoleaks requiring re-intervention, graft limb occlusion, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm
次要结局
未报告次要终点