ARCHYTAS: AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 500
- 试验地点
- 37
- 主要终点
- Treatment Success
研究概览
简要总结
The ARCHYTAS Registry is a long-term, global, multicenter, non-randomized, prospective, registry designed to collect "on-label" data in real world clinical settings on patients undergoing endovascular repair with the latest generation Aorfix™ AAA Flexible Stent Graft System. Registry data will augment existing data from ongoing and prospective Aorfix™ clinical trials for the purposes of publication, general product development and quality measures.
详细描述
The ARCHYTAS Registry is a long-term, global, multicenter, non-randomized, prospective, registry established by Lombard Medical Ltd. (Lombard) to collect "on-label" data in real world clinical settings on patients undergoing endovascular repair with the latest generation Aorfix™ AAA Flexible Stent Graft 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°. This indication for Aorfix™ is approved in all territories where this Registry is being operated and this Registry does not seek to collect data on any use of the implant for which full commercial approval does not already exist.
The ARCHYTAS Registry data will augment existing data from ongoing and prospective clinical trials with Aorfix™ for the purposes of publication, general product development and quality measures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 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.
排除标准
- •Does not comply with the indications for Aorfix™ in the Instructions for Use (IFU).
- •Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care at the investigative site.
- •Unwillingness or inability to provide informed consent to both the Registry 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
Treatment Success
时间窗: 12 months
Defined as freedom from the following: * Sac expansion \> 5mm * Type I and III endoleaks requiring re-intervention * Rupture * Conversion to open surgery * Stent graft migration \> 10 mm * Stent graft occlusion
次要结局
- Graft Performance(30 Days to 12 Months)