An EU Post-Approval Registry of the TREO® Stent-Graft for Patients With Infrarenal Abdominal Aortic Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 174
- 试验地点
- 20
- 主要终点
- Stroke (excluding transient ischemic attack)
研究概览
简要总结
This is an EU sponsored trial and independent of the US trial registered under Clinicaltrials.gov ID NCT02009644.
The purpose of this registry is to gather clinical data on the safety and performance of the TREO Stent-Graft in patients with infrarenal abdominal aortic aneurysms. The registry is part of TREO's EU post-market surveillance plan providing long-term systematic clinical follow-up.
详细描述
This is a prospective, multicenter, post-market clinical follow-up, non-randomized registry of the TREO Stent-Graft. Subjects diagnosed with infrarenal aortic aneurysms and treated with the TREO Stent-Graft or TREO aorto-uni-iliac (AUI) device can be included into the registry. Pre-procedure baseline data will be gathered as well as post-procedure assessments prior to hospital discharge and one to three months and 1, 2, 3, 4, and 5-year post-implantation.
The objective of the registry is to assess the clinical results and health economics of the TREO device in a real-world population of patients with infrarenal abdominal aortic aneurysms (AAA).
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
- •Age > 18 years
- •Signed informed consent
- •Willingness to comply with study follow-up
- •Indication for elective endovascular repair
- •Planned implantation of single Treo device system or aorto uni-iliac (AUI) device to include any auxiliary device components
排除标准
- •Intolerance to contrast media
- •Emergency procedure
- •Chimneys or fenestrated device procedures
- •Connective tissue disease (e.g., Marfan's syndrome)
- •High probability of non-adherence to follow-up requirements
- •Current participation in a concurrent trial that may confound study results
- •Female of childbearing potential in whom pregnancy cannot be excluded
- •Previous endovascular or surgical AAA repair
结局指标
主要结局
Stroke (excluding transient ischemic attack)
时间窗: 30 days post-procedure
Respiratory failure
时间窗: 30 days post-procedure
excluding chronic obstructive pulmonary disease or pulmonary complications)
Bowel ischemia
时间窗: 30 days post-procedure
A restriction in blood supply to tissues in the bowels
Aneurysm-related mortality
时间窗: 30 days post-procedure
Renal failure
时间窗: 30 days post-procedure
Renal failure requiring renal replacement therapy (excluding renal insufficiency)
Myocardial infarction
时间窗: 30 days post-procedure
Raised cardiac enzymes within 30 days of the procedure
Paraplegia
时间窗: 30 days post-procedure
(excluding paraparesis)
Treated aneurysm rupture
时间窗: 30 days post-procedure
次要结局
- Major Adverse Events (MAE) at the follow-up time points(30 days post-procedure)
- Limb Ischemia(30 days post-procedure)
- Vascular access complications(Vascular access will be evaluated on day of index procedure (implant))
- Secondary procedures(5 years)
- Patient-reported quality of life (QOL)(One year follow-up)