A Prospective, Multicenter, Open, Randomized Controlled, Non Inferiority Clinical Trial to Evaluate the Safety and Efficacy the Branch-based Intraoperative Stent System in the Treatment of Stanford A Aortic Dissection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 259
- 试验地点
- 19
- 主要终点
- All cause mortality
研究概览
简要总结
The purpose of the study was to evaluate the safety and efficacy of a branched type intraoperative stent system for the treatment of Stanford type A aortic dissection
详细描述
Types The clinical trial design was prospective, muticenter, open, randomized controlled design with an additional single group design.
Plan Before the randomized controlled trial, each center will enroll one subject as a learning curve case（only use PerMed double branched structures）. 212 participants were planned to be enrolled from no less than 10 qualified clinical research institutions and randomly assigned 1:1 to the intraoperative stent systems of Endovastec and the branched type intraoperative stent systems of PerMed double branched structures. An additional 30 subjects were enrolled using a branched type intraoperative stent system with a single branch structure from PerMed, Beijing.
All enrolled participants were followed up clinically intraoperatively, before discharge or 30 days ± 7 days after procedure, 6 months ± 30 days after procedure, 12 months ± 30 days after procedure, and 2-5 years after procedure.Non inferiority of the trial product to the control product was assessed with the primary end point of all-cause mortality at 12 months after procedure. The statistical analysis and summary report will be conducted based on the 12-month follow-up data of all subjects, and the application for medical device registration will be carried out. The long-term efficacy and safety evaluation of the product will be carried out after long-term follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 75 years, male or female;
- •Stanford type A aortic dissection subjects with involvement of the descending arch aorta；
- •Subjects treated with stent pictorial procedures as judged appropriate by the investigator；
- •Subjects or their legal surrogates were able to understand the purpose of the study, had adequate compliance to the clinical study protocol, and voluntarily signed the informed consent form.
排除标准
- •Subjects with aortic dissections confined to the ascending and / or arch
- •Subjects with a left common carotid artery branch vessel diameter < 5 mm or > 16 mm (not applicable to subjects enrolled with a single branch structure)
- •Subjects with a left subclavian artery branch vessel diameter < 7 mm or > 16 mm
- •Subjects with aortic dissection with severe malperfusion syndrome preoperatively (e.g., subjects presenting with coma, paraplegia, need for dialysis, gastrointestinal necrosis or limb necrosis due to ischemia, etc.)
- •Subjects with vertebral artery variants
- •Subjects with infectious aortic dissections
- •Subjects with acute systemic infection, severe infection and associated sepsis, shock or multiple organ failure
- •Subjects unable to tolerate anaesthesia and cardiopulmonary bypass
- •Subjects who had undergone open surgical procedures of the cardiocerebral vasculature within 90 days prior to surgery
- •Subjects with history of active bleeding, coagulopathy or refusal of blood transfusion
- •Subjects known to be allergic to materials such as contrast agents, nitinol alloys, coated artificial blood vessels
- •Subjects with a life expectancy of less than 12 months (other than disease due to aortic dissection)
- •Subjects being enrolled in other clinical trials
- •Pregnant and lactating women, and subjects with a recent pregnancy preparation
- •Subjects with poor compliance other conditions that the investigator considers inappropriate for participation in the clinical trial.
结局指标
主要结局
All cause mortality
时间窗: after procedure 1 year
Percentage of subjects who died from any cause within 12 months ±30 days
次要结局
- Mortality associated with aortic dissection(30 day)
- Incidence of device-related adverse events(6month，1 year，5 year)
- Branch patency(1 year)
- Device implantation success rate(Immediately after implantation)
- Operation success rate(Immediately after procedure)
- Incidence of acute kidney injury(1 year)
- false-lumen thrombosis rates(6 month, 1 year)
- Secondary intervention rate of target lesions(1 year)
- stroke rate(1 year)
- Incidence of spinal cord ischemia(1 year)
- 30 day all-cause mortality after procedure(30 day)