NCT01688050已完成不适用
TRANSFIX - Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 42
- 主要终点
- All-cause Mortality
研究概览
简要总结
The TRANSFIX study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® TX2® Low Profile Endovascular Graft for treatment of Blunt Thoracic Aortic Injury.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vessels suitable for endovascular access and stent graft placement
- •Blunt thoracic aortic injury of the descending thoracic aorta
- •At least 16 years of age
- •Informed consent given by patient or legally authorized representative
排除标准
- •Clinical considerations that would compromise patient safety or study outcomes
- •Unsuitable arterial anatomy
结局指标
主要结局
All-cause Mortality
时间窗: 30 days
Aortic Injury-related Mortality
时间窗: 30 days
Any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the transected aorta.
Device Success
时间窗: 30 days
Technical success (successful access, deployment, and patency of the Zenith® TX2® Low Profile Endovascular Graft), and freedom from the following: device collapse, type I or type III endoleaks requiring reintervention, and conversion to open surgical repair.
次要结局
未报告次要终点
研究者
研究点 (42)
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