Endovascular Exclusion of Thoracoabdominal Aortic Aneurysms or Abdominal Aneurysms Utilizing Fenestrated/Branched Stent-Grafts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,366
- 试验地点
- 1
- 主要终点
- Freedom From Aneurysm Rupture
研究概览
简要总结
The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms.
详细描述
The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms. The evaluation shall be conducted with subjects that would be expected to have great difficulty tolerating open surgical repair and anatomies not suitable for devices currently marketed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •At least 18 years of age.
- •Not pregnant
- •Willing and able to comply with two-year follow-up period.
- •Willing and able to give informed consent prior to enrollment
- •No known allergy to stainless steel or polyester
- •No history of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately.
- •Life expectancy greater than two years
- •High risk candidate for open surgical repair
排除标准
- 未提供
研究组 & 干预措施
Endovascular Aneurysm Repair
Endovascular Aneurysm Repair of TAAA/AAA with Fenestrated/Branched Stent Grafts
干预措施: Endovascular Aneurysm Repair (Device)
结局指标
主要结局
Freedom From Aneurysm Rupture
时间窗: 2 years
Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan
次要结局
未报告次要终点
研究者
Behzad Farivar, M. D.
Principal Investigator
The Cleveland Clinic