NCT01663064已完成不适用
Zenith® p-Branch™: Single-Center Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Technical Success
研究概览
简要总结
The Zenith® p-Branch™: Single-Center Study is a clinical trial approved by Swedish Regulatory Authority to study the safety and effectiveness of the Zenith® p-Branch™ 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
- •Pararenal or juxtarenal AAA >5.0 cm in diameter
- •Pararenal or juxtarenal AAA with history of growth >0.5 cm/year
排除标准
- •Age < 18 years
- •Life expectancy < 2 years
- •Pregnant or breast feeding
- •Inability or refusal to give informed consent by the patient or a legally authorized representative
- •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: Up to 5 years
Technical success is described as: 1) successful access of the aneurysm site, 2) successful deployment of the Zenith® p-Branch™ endovascular graft in the intended location, 3) Zenith® p-Branch-™ endovascular graft is patent at deployment completion as evidenced by intraoperative angiography, and 4) all vessels targeted with a fenestration are patent at deployment completion as evidenced by intraoperative angiography.
次要结局
未报告次要终点
研究者
研究点 (2)
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