Post-market Study on Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms
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
- 20
- 主要终点
- Surgical or endovascular secondary procedures
研究概览
简要总结
The purpose of this study is to assess the benefits of endovascular repair with Endurant Stent Graft System by documenting overall mortality, complications, the rate of conversion to open surgical repair, and the development and rupture of the aneurysm on a long term, i.e. at 5 years, in a cohort of patients representative of the population treated under real-life conditions of use in France.
详细描述
Data regarding the use under routine practice of abdominal aortic stent grafts in France are expected by the French National Authority for Health (HAS). Therefore, in its opinion report from July 13, 2010, HAS makes the maintenance of reimbursement approval of each stent graft dependent on the presentation of results of a specific follow-up study carried out in a cohort of patients representative of the French population treated under real-life conditions of use. This prospective cohort study must involve at least 150 patients implanted after registration on the LPPR (List of Products and Services qualifying for Reimbursement). The results of the follow-up study must be forwarded to the National Committee for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) for examination once a year. The assessment of this follow-up could lead to the recommendation by CNEDiMTS to continue or stop the reimbursement of the concerned stent graft.
In France, The Endurant™ Stent Graft System is registered on the LPPR for a period of 3 years since September 13, 2011. In order to comply with HAS expectations, Medtronic Bakken Research Center is setting up this long term non-interventional study on the Endurant stent graft.
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 with age ≥18 years, who is able to understand the information given by the investigator regarding the collection and release of his/her personal information and who is able to oppose to this collection and release.
- •Any patient requiring placement of an abdominal aortic stent graft for the treatment of a non-ruptured infra-renal abdominal aortic aneurysm.
- •Patient not opposed to the collection and release of his/her personal information
- •Intention of physician to implant electively the Endurant™ Stent Graft System
排除标准
- •Patient in whom clinical follow-up will not be possible i.e. patient not able to come back for follow-up visits (ex. patient living abroad)
结局指标
主要结局
Surgical or endovascular secondary procedures
时间窗: through 5 years
Aneurysm diameter's change
时间窗: through 5 years
Conversion to open surgical repair
时间窗: through 5 years
Stent graft endoleaks (type I, II and III)
时间窗: through 5 years
Aneurysm-related mortality
时间窗: through 5 years
All-cause mortality
时间窗: through 5 years
Stent Graft migration
时间窗: through 5 years
次要结局
未报告次要终点