Real-world Experience With the Castor Single Branch Stent Graft in the Management of Acute Aortic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Immediate post-operative technique success
研究概览
简要总结
The objective of this study to evaluate the safety and effectiveness of the Castor single branch stent graft for endovascular repair of acute aortic syndrome patients without an inadequate proximal landing zone (<15mm)
详细描述
The goal of this observational, ambispective, and multicenter cohort study is to evaluate efficacy and safety of the Castor single branch stent graft.
205 patients who received thoracic endovascular aortic repair by meant of the Castor single branch stent graft from June 2018 to June 2022 were enrolled in our study. All enrolled patients have an inadequate proximal landing zone (<15mm) , and they underwent routine follow-up after thoracic endovascular aortic repair at 1-month, 6-months, and 1-year for the following, but not limited to assessment: physical examination, laboratory test and the CT angiography.
Meanwhile, the enrolled patients will come for continuous follow-up at 2-years, 3-years, and annually to 10-years post-procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute Stanford type B aortic syndrome who received thoracic endovascular aortic repair by meant of Castor single branch stent graft from June 2018 to June 2022
排除标准
- •Patients with acute type B aortic syndrome with an adequate proximal landing zone (≥15mm)
- •Previous endovascular repair of the aorta
- •Patients with missing data and loss of follow-up
结局指标
主要结局
Immediate post-operative technique success
时间窗: immediately post operation
Immediate technical success is defined as successful delivery of the aortic and branching stent graft conveyors to their predetermined position, accurate positioning and successful deployment of the stent, safe removal of the delivery device outside the body, absence of Type I and III endoleaks on angiography at the end of the procedure, and patent branch stents.
All-cause mortality and major
时间窗: 1-year post operation
All-cause mortality includes aortic mortality, non-aortic mortality, and mortality from unknown causes.
次要结局
- Aortic remodeling results as assessed by computer tomography angiography (the size of the true and false lumen of aorta, and the thrombosis degree of the false lumen of aorta)(1-month, 6-months, 1-year, and annually to 10-years post operation)
- Major device/procedure-related adverse events of post-operation as assessed by computer tomography angiography(1-month, 6-months, 1-year, and annually to 10-years post operation)
- Re-intervention during follow-up(1-month, 6-months, 1-year, and annually to 10-years post operation)