NCT02396199已完成不适用
Zenith® p-Branch® Pivotal Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 52
- 主要终点
- Treatment Success Proportion
研究概览
简要总结
The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents 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 or 2 times the normal aortic diameter
- •Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year
- •Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation
排除标准
- •Age <18 years
- •Life expectancy <2 years
- •Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
- •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
- •Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)
- •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
Treatment Success Proportion
时间窗: 12 months
Technical success and freedom from type 1 and type 3 endoleaks which require intervention, aneurysm growth, related SAE's, and related major complications
次要结局
未报告次要终点
研究者
研究点 (52)
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