EVAR Treatment With the Endurant Stent Graft of Challenging Anatomy in Experienced Hands, the Real World Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Clinical success
研究概览
简要总结
The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the Endurant for Challenging Anatomy: Global Experience (EAGLE) Registry. The aim of this study is to collect clinical information on the performance of the Endurant Stent Graft System for endovascular repair in anatomically challenging aneurysms, and to critically assess whether the current guidelines for anatomic eligibility to endovascular treatment with this system are still applicable. This study aims at creating a database that can be pooled/ compared with the ENGAGE database.
This study aims at answering two major questions:
- Is the technical success rate of successful delivery and deployment of the Endurant (II) similar in anatomically challenging aneurysm?
- Is the successful treatment rate comparable in anatomically challenging aneurysms, or does treatment of these aneurysms lead to more complications and reinterventions?
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Age ≥ 18 years or minimum age as required by local regulations
- •Indication for elective EVAR
- •Challenging AAA anatomy
- •Intention to electively implant the Endurant or Endurant II Stent Graft System©
- •Signed informed consent form
排除标准
- •Subjects with intolerance to contrast media
- •Chimneys or fenestrated device procedures
- •High probability of non-adherence to physician's follow-up requirements
- •Current participation in a concurrent trial that may confound study results
结局指标
主要结局
Clinical success
时间窗: 12 months
Freedom from: * Increase of AAA diameter \> 5 mm (1 month measurement as baseline) * Type I\&III endoleaks * Aneurysm rupture * Conversion to surgery * Stent graft migration (\>10mm) resulting in SAE or reintervention * Stent graft occlusion
次要结局
- Helath Related Quality of Life Scores(12 months)
研究者
Joep Teijink
MD, PhD
Catharina Ziekenhuis Eindhoven