NCT02471781Approved For Marketing不适用
Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
- 试验地点
- 15
研究概览
简要总结
The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is indicated for the treatment of patients with a descending thoracic aortic aneurysm or penetrating ulcer and has an anatomy suitable for 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
- •Meets one of the following
- •Descending thoracic aneurysm with diameter ≥ 5.0 cm
- •Descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year
- •Descending thoracic degenerative or atherosclerotic ulcer ≥ 10 mm in depth and 20 mm in diameter
排除标准
- •Life expectancy less than 2 years
- •Pregnant of breastfeeding or planning on becoming pregnant within 60 months
- •Unwilling to comply with the follow-up schedule
- •Less than 30 days beyond primary endpoint for other investigative drug or device study
- •Receiving home oxygen
- •Myocardial infarction within the last 3 months
- •Stroke within the last 3 months
- •Diagnosed or suspected congenital degenerative collagen disease
- •Systemic infection
- •Bleeding diathesis, uncorrectable coagulopathy, or refuses blood transfusion
- •Allergy to polyester, polypropylene, nitinol, or gold
- •Previous placement of a thoracic endovascular graft
- •Prior open repair involving the descending thoracic aorta
研究者
研究点 (15)
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