Aorfix™ Generation IV Delivery System "IntelliFlex™" Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- Number of participants with Successful Implant Delivery (30d)
研究概览
简要总结
The First In Human (FIH) study is a long-term, single center, non-randomized study established by Lombard Medical, Inc. to collect "on-label" data in the clinical setting on patients undergoing endovascular repair with IntelliFlex™, the latest generation of the Aorfix™ AAA Flexible Stent Graft Delivery System, for treatment of abdominal aortic and aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an angle between 0° and 90°.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed abdominal aortic aneurysm with indication for endovascular repair.
- •Intention to electively implant the Aorfix™ Stent Graft System with IntelliFlex™ Delivery Device.
排除标准
- •Do not comply with the indications for Aorfix™ in the IFU.
- •Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care of the investigative site.
- •Unwillingness or inability to provide informed consent to both the study and the EVAR procedure.
- •Patients in whom Aorfix™ is being placed as a secondary procedure to a previous surgical or endovascular treatment of an AAA other than with another Aorfix™ graft.
结局指标
主要结局
Number of participants with Successful Implant Delivery (30d)
时间窗: 1 Month
Successful implant delivery is also called Primary Technical Success, defined as successful introduction and deployment of the device in the absence of surgical conversion or mortality, Type I or III endoleaks, or graft limb obstruction. The numbers of participants having Primary Technical Success on completion of the index procedure and Clinical Success 12 months after the procedure will be recorded.
Number of participants with Treatment Success (1year)
时间窗: 12 Months
Treatment success, or Clinical Success, requires successful deployment of the endovascular device at the intended location without death as a result of aneurysm-related treatment, Type I or III endoleak, graft infection or thrombosis, aneurysm expansion (diameter \>=5 mm, or volume \>=5%), aneurysm rupture, or conversion to open repair. The numbers of participants having Primary Technical Success on completion of the index procedure and Clinical Success 12 months after the procedure will be recorded.
次要结局
未报告次要终点