A Prospective, Multicenter, Objective Performance Criteria-Controlled Study for National Medical Products Administration Approval Of The Thoracic Aortic Stent Graft System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 14
- 主要终点
- Rate of no Major Adverse Event (MAE)
研究概览
简要总结
This is a prospective, multicenter and single-arm trail to study the safety and efficacy of the thoracic aortic stent graft system that specially designed for treating aortic dissection.
详细描述
This trail is conducted in several centers all around China. In about 18 months, 120 subjects with aortic dissection will be recruited, all of which receive endovascular treatment using the thoracic aortic stent graft system (Zylox-Tonbridge Medical Technology Co., Ltd. ). The subjects will be followed up in 30 days/ 6 months/ 12 months/ 2-5 years.
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 18 to 80 years;
- •Subject or legal representative is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent；
- •Subjects who are diagnosed with Stanford type B aortic dissection requiring reconstruction of the left common carotid artery and left subclavian artery or requiring reconstruction of the left subclavian artery;
- •Appropriate access to the femoral artery, iliac artery, brachial artery, etc. that can be used for endoluminal aortic therapy.
排除标准
- •The same surgery requires intervention for other vascular lesions；
- •History of surgery in the aortic arch or endovascular repair surgery;
- •Severe stenosis or calcification or distortion in the anchoring area of the proximal end of the stent;
- •Subjects with severe liver, kidney failure；
- •Subjects with severe coagulation disorders；
- •Female subjects who are pregnant, lactating within the study period or unable to contraception during the trail.
- •History of allergies to anesthetics, contrast agents or the material of stent/ deliver system；
- •Inability to tolerate anesthesia；
- •History of acute myocardial infarction, cerebral infarction or cerebral hemorrhage within 3 months before surgery;
- •Subjects who have participated in any other drug or medical device clinical investigations and haven't reach the primary endpoint.
- •Subjects with acute systemic infection
- •Other circumstances judged by researchers that are not suitable for enrollment .
结局指标
主要结局
Rate of no Major Adverse Event (MAE)
时间窗: 30 days
MAE was defined as aortic dissection related death, disabling stoke or paraplegic.
Success rate of endovascular treatment
时间窗: Up to 12 months
* Technique success: the delivery system was successfully delivered to the predetermined position, the stent was accurately positioned and successfully deployed, and the delivery system could be safely withdrawn from the body, no type I or type III endoleak can be found during angiography. * No stent displacement during 12 months follow up time. * No secondary surgical intervention during 12 months follow up.
次要结局
- Success rate of endovascular repair(30 days/ 6 months/ 12 months)
- Rate of all cause mortality(Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years)
- Rate of Adverse Events(AE)(Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years)
- Rate of aortic dissection related mortality(Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years)
- Rate of Serious Adverse Events(SAE)(Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years)
- Rate of technique success(Immediately after the intervention)
- Incidence of stent displacement(30 days/ 6 months/ 12 months)