Safety and Efficacy Study of Fabulous Stent Graft System for Stanford B Aortic Dissection: A Prospective, Multi-center, Single Arm, Objective Performance Criteria Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 24
- 主要终点
- Number of patients with no incidence of major surgical or device related adverse events rate
研究概览
简要总结
A prospective, multi-center, objective performance criteria clinical trial to evaluate the safety and efficacy of Fabulous Stent Graft System manufactured by Hangzhou Endonom Medtech Co., Ltd. for Stanford B Aortic Dissection.
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
- •Patients ≥18 years old;
- •The informed consent was signed by the patient or the legal representative;
- •Diagnosed with Stanford B aortic dissection;
- •The proximal anchoring area of is 18-42 mm in diameter, and not less than 15mm in length;
- •Has a suitable arterial approach and is suitable for surgical treatment.
排除标准
- •The patient's distal vascular false cavity has been completely thrombotic or organized;
- •Pregnant or breastfeeding ;
- •Has participated in clinical trials of other devices ；
- •History of aortic surgery or endovascular repair surgery ;
- •Allergic to contrast agents and anesthetics ;
- •Allergic to stents or conveyors ;
- •Patients with true or false aortic aneurysm;
- •History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
- •Life expectancy is less than 12 months;
- •Other situations in which the investigator judges that not suitable for endovascular treatment .
研究组 & 干预措施
Fabulous Stent Graft System
All patients received endovascular surgery using fabulous stent graft system
干预措施: Fabulous Stent Graft System (Device)
结局指标
主要结局
Number of patients with no incidence of major surgical or device related adverse events rate
时间窗: within 30 days after surgery
Surgical or device related major adverse events (MAE) : death, respiratory failure, renal failure, stroke, paraplegia, intestinal ischemia, cardiovascular and vascular complications caused by surgery or device
Clinical success rate
时间窗: 12 months after surgery
Clinical success is defined as : no displacement of Stent Graft System, no type I or III endoleak requiring treatment, no enlargement of the false lumen, thrombosis of the false lumen, and no rupture of the dissection
次要结局
- Endoleak rate(within 12 months after surgery)
- adverse event rate(within 12 months after surgery)
- Immediate operation successful rate(immediately after the surgery)
- Immediate delivery success rate(immediately after the surgery)
- Secondary surgical treatment rate(within 12 months after surgery)