NCT01327742Approved For Marketing不适用
Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies
Bolton Medical15 个研究点 分布在 1 个国家开始时间: 2011年4月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
- 发起方
- 试验地点
- 15
研究概览
简要总结
This study is a continuation of the pivotal trial studying the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is being evaluated by the device-related adverse event rate of endovascular repair (via the Relay thoracic stent-graft) through 1 year. Safety is being evaluated by comparing major adverse events through 1 year in subjects treated with the Relay thoracic stent-graft to those who underwent surgical repair.
研究设计
- 研究类型
- Expanded Access
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
- •Subjects with diagnosed descending thoracic aneurysm or penetrating ulcer
- •Subjects whose anatomy can accommodate the Relay device
- •Subjects who consent to participate
- •Subjects who agree to a follow-up schedule
排除标准
- •Subjects with lesions other than thoracic aneurysm and penetrating ulcer
- •Subjects with less than 1 year life expectancy
- •Subjects who are pregnant
- •Subjects with medical conditions that wold complicate the endovascular procedure or confound results (e.g., Marfan's syndrome, morbid obesity, severe coronary artery disease)
- •Subjects participating in another investigational study
研究者
研究点 (15)
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