NCT02266342已完成不适用
Evaluation on the Treatment of Diseases of the Thoracic Aorta With the Thoracic Endoprosthesis GORE® TAG®
W.L.Gore & Associates1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2014年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Number of Subjects With All-cause Mortality (Long-term)
研究概览
简要总结
This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® TAG® Thoracic Endoprosthesis treating diseases of the thoracic aorta.
详细描述
Endovascular therapy to treat thoracic disease seems to provide a plausible benefit compared to surgery in terms of operative mortality and severe morbidity. The French National Health Authority (HAS) requires a 5-year follow-up as part of the renewal of reimbursement for these endoprostheses in order to collect long-term follow-up data under real-life conditions of use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient where a GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis is implanted (successfully or not) for the treatment of disease of the descending thoracic aorta.
- •Patient who had previously consented to the collection and processing of personal medical data.
- •Patient older than 18 years at the time of treatment.
排除标准
- •Patients who have already received treatment with a thoracic endoprosthesis other than the GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis and for whom 'revision' or reintervention is required.
- •Patients whose clinical follow-up is not possible (i.e. patients who cannot return for control visits because they live abroad).
结局指标
主要结局
Number of Subjects With All-cause Mortality (Long-term)
时间窗: 5 years
次要结局
- Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture(5 years)
- Number of Subjects With Cardiac, Renal, and Pulmonary Complications(5 years)
- Number of Subjects With Device-related Complications(5 years)
- Number of Subjects With Disease Related Mortality(5 years)
- Number of Subjects With Neurological Complications(5 years)
- Number of Subjects With Surgical Conversion(5 years)
- Number of Subjects With Secondary Procedures(5 years)
研究者
研究点 (1)
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