Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 53
- 主要终点
- Primary Safety Endpoint: Distribution of Major Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft) through 1-year. Safety will be evaluated by comparing major adverse events through 1-year in subjects treated with the Relay Thoracic Stent-Graft to those who underwent surgical repair. Long term follow-up is conducted through 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Subjects with diagnosed descending thoracic aortic aneurysms or penetrating atherosclerotic ulcers
- •Subjects who are at least 18 years of age
- •Subjects whose anatomy can accommodate the Relay device
- •Subjects who consent to participate
- •Subjects who agree to comply with follow-up schedule
排除标准
- •Subjects with non-aneurysm lesions
- •Subjects with less than 1 year life expectancy
- •Subjects who are pregnant
- •Subjects with medical conditions that would complicate the endovascular procedure or confound the results (e.g., Marfan's Syndrome, prior repair in the thoracic aorta, severe coronary artery disease, morbid obesity, etc.)
- •Subjects participating in another investigational study
研究组 & 干预措施
1
Endovascular Treatment arm to be implanted with Relay device
干预措施: Relay Thoracic Stent-Graft (Device)
2
Surgical Control, underwent open repair
干预措施: Open Repair (Procedure)
结局指标
主要结局
Primary Safety Endpoint: Distribution of Major Adverse Events
时间窗: 1 year
The primary safety endpoint was the distribution of participants experiencing at least 1 of the major adverse events (aneurysm-related mortality, stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, and wound healing complications) within 1 year post-procedure
Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects
时间窗: 1 year
The primary effectiveness endpoint was freedom from major device-related adverse events \[endoleak (Types I, III and IV), stent migration (\> 10mm as compared to the 1 month visit), lumen occlusion, aneurysm rupture, and deployment failure/conversion to surgical repair\] at 1 year post-procedure. The proportion of participants in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.
次要结局
未报告次要终点