NCT02663739已完成不适用
Zenith TXD Dissection Stent Graft System Usage Results Surveillance in Japan for Treating Acute Complicated Stanford Type B Aortic Dissection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 27
- 主要终点
- Rate of major adverse events
研究概览
简要总结
The study is a post-market surveillance study required by Japanese Regulatory Authorities as a condition of approval
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with thoracic aortic dissection, including attempted cases
- •Patients with acute Stanford type B aortic dissection, including attempted cases
排除标准
- •Stanford type A aortic dissection and/or chronic type B aortic dissection
结局指标
主要结局
Rate of major adverse events
时间窗: 5 years
Major adverse events will include death, aortic rupture, conversion to open surgical repair, spinal cord ischemia, retrograde progression of dissection, myocardial infarction, renal failure requiring dialysis, intestinal ischemia, stroke, paraplegia, and \> 72 hours artificial respiratory assistance.
次要结局
未报告次要终点
研究者
研究点 (27)
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