A Multi-center Trial of Castor Single-Branched Stent Graft System for Endovascular Repair of Aortic Dissection.
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- success rate of endovascular repair
研究概览
简要总结
Aim:Castor is a novel single-branched stent graft system for endovascular repair of aortic arch dissection. This is a prospective, one-arm, open, multi-center, pre-market study of Castor stent to evaluate its efficacy and safety in treatment of aortic dissection.
Number of patients: 70 patients will be included and undertaken endovascular repair with Castor stent.
Follow-up: 1.aortic computed tomographic angiography (CTA) examination 6 and 12 months after the surgery 2.telephone or clinical follow-up 30 days and 2-5 years after the surgery
Primary Outcome Measure: success rate of endovascular repair for efficacy measurement.
Secondary Outcome Measure: 1 year stent related adverse event rate for safety measurement.
Other Outcome Measures:
- efficacy:
- 1 year success rate of treatment
- 1 year patency rate of branch stent
- safety:
- in-hospital mortality
- complication rate of neural system
- 1 year dissection or stent related mortality
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age from 18 to 80, male or unpregnant female
- •diagnosed as aortic dissection
- •proximal tear of the dissection locates between 15mm to the distal end of left common carotid artery and 20mm to the distal end of left subclavian artery (LSA) or inverse tear to LSA
- •good compliance with the instructions and cooperate with follow-up
- •voluntarily signed the informed consent form
排除标准
- •Pregnant female
- •no appropriate vessel approaches
- •patients with connective tissue diseases (such as Marfan syndrome)
- •allergic to nitinol or contrast medium
- •bad compliance with the instructions and follow-up
- •estimated remaining life is less than 12 months
研究组 & 干预措施
Castor Stent Graft
To study the safety and efficacy of Castor single-branched stent graft system in endovascular repair of aortic dissection.
干预措施: Castor Stent Graft (Device)
结局指标
主要结局
success rate of endovascular repair
时间窗: during the surgery
- during the surgery: successful conduction, accurate positioning and release, and no warping, folding, narrowing or blocking of the stent graft system. Immediately after the stent release, angiography shows both main stent and side arm stent patency, successful exclusion of dissection and no arteriorrhexis or dissection rupture.
次要结局
- 1 year stent related adverse event rate(1 year)
研究者
Zaiping JING
Director of Department of Vascular Surgery
Changhai Hospital