The Performance of the Endurant Endoprosthesis in an Infrarenal Aortic Aneurysm With a Wide or Conical Shaped Infrarenal Neck Anatomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- Freedom from reinterventions at one year
研究概览
简要总结
Retrospective single centre observational cohort study of patients who underwent an elective infrarenal abdominal aortic aneurysm repair, from January 2011 to January 2020.
详细描述
Objective
To evaluate the performance of the Endurant endoprothesis in patients with a wide or conical shaped neck anatomy after elective abdominal aortic aneurysm repair.
Inclusion: Patients who underwent elective infrarenal abdominal aortic aneurysm repair with the Endurant endograft between January 2011 until January 2020 in Rijnstate, Arnhem, the Netherlands.
Primary endpoint: Freedom from reinterventions at one year.
Secondary outcomes:
- Endoleaks
- Aneurysm sac growth
- Aneurysm rupture
- Stent migration
- AAA-related mortality
- All-cause mortality
- Procedural time
- 30-day complications
- Renal dysfunction/renal occlusion
- Proximal fixation failure
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with an elective infrarenal endovascular abdominal aortic aneurysm repair with the Endurant endoprothesis between January 2011 till January 2020 in the Rijnstate hospital, Arnhem, the Netherlands.
排除标准
- •emergency/rupture procedures
- •objection use of data for research
- •other prosthesis used for EVAR
研究组 & 干预措施
conical neck group
patients with an abdominal aortic aneurysm and a conical neck
干预措施: EVAR (Procedure)
Wide neck group
patients with an abdominal aortic aneurysm and a wide neck (>28 mm diameter)
干预措施: EVAR (Procedure)
straight neck group
patients with an abdominal aortic aneurysm without a wide or conical neck
干预措施: EVAR (Procedure)
结局指标
主要结局
Freedom from reinterventions at one year
时间窗: one year
reintervention-free survival will be evaulated using kaplan meier method
次要结局
- Freedom from reinterventions throughout follow-up (up to ten years)(10 years)
- the number of patients showing aneurysm sac growth(10 year follow-up)
- Number of endoleaks(10 year follow-up)
- the number of patients with an aneurysm rupture during follow-up(10 year follow-up)
- the number of patients showing stent migration(10 year follow-up)
- the number of patients showing proximal fixation failure(10 year follow-up)
- Number of patients with AAA related mortality(10 year follow-up)
- All-cause mortality(10 year follow-up)
- The number of patients with 30-day complications(30 days)
- The number of patients with renal dysfunction/renal occlusion(10 year follow-up)