NCT00813358已完成不适用
Zenith TX2® TAA Endovascular Graft Post-approval Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 49
- 主要终点
- Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality
研究概览
简要总结
The Zenith TX2® Post-market Approval Study is a clinical trial approved by US FDA to further study the safety and effectiveness of the Zenith TX2® TAA Endovascular Graft in the treatment of thoracic 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
- •Descending thoracic aortic aneurysm with diameter greater than or equal to 5.0 cm; or
- •Descending thoracic aortic aneurysm with a history of growth greater than or equal to 0.5 cm within the previous 12 months; or
- •Descending thoracic aortic degenerative or atherosclerotic ulcers greater than or equal to 10 mm in depth and 20 mm in diameter
排除标准
- •Age less than 18 years
- •Other medical condition that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., less than 2 years)
- •Pregnant, breast-feeding, or planning on becoming pregnant within 24 months
- •Unwilling or unable to comply with the follow-up schedule
- •Inability or refusal to give informed consent
- •Simultaneously participating in another investigative device or drug study
结局指标
主要结局
Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality
时间窗: 5 years
Thoracic aortic aneurysm-related mortality defined as death from any cause occurring within 30 days of the initial procedure or a secondary intervention; or any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the treated aneurysm.
次要结局
未报告次要终点
研究者
研究点 (49)
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