Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch Unique Embedded Aortic Triple-branch Arch Stent Graft System (GENIUS Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 20
- 主要终点
- Rate of all-cause mortality and major stroke within 12 months after surgery
研究概览
简要总结
A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/pseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study)
详细描述
This study is a prospective ,multiple center study about the safety and efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System , it is expected to complete the implantation of 90 patients in 20 centers within 20 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24th month, 36th month, 48th month and 60th month postoperatively.
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
- •Patients aged 18 to 80 years old;
- •Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch;
- •Showing a suitable vascular condition, including:
- •Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).
- •Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;
- •Proximal anchoring zone length ≥ 30 mm;
- •Branch arteries to be reconstructed were ≤ 24 mm and ≥ 6 mm in diameter and ≥ 20 mm in length;
- •Suitable arterial access for endovascular interventional treatment;
- •Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.
- •Subjects were assessed as high risk for surgery by at least two investigators or judged to have significant surgical contraindications. Recommended reference criteria were a European system for cardiac operative risk evaluation (EuroScore) score of 6 or higher or other surgical risk factors as judged by the physician team.
排除标准
- •Experienced systemic infection during past three months;
- •Neck surgery was performed within 3 months;
- •Previous endovascular interventional treatment involving the aortic arch was performed;
- •Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue diseases );
- •Severe stenosis, calcification, thrombosis, or tortuosity of the branch artery to be reconstructed;
- •Heart transplant;
- •Suffered Myocardial Infarction or Stroke during past three months;
- •Class IV heart function (NYHA classification);
- •Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months;
- •Hematological abnormality, defined as follows: Leukopenia (WBC < 3 ×109/L), acute anemia (Hb < 90 g/L), Coagulation disorders, thrombocytopenia (PLT count < 50 × 109/L);
- •Renal insufficiency, creatinine > 150 umol/L and/or end-stage renal disease requiring renal dialysis;
- •Pregnant or breastfeeding;
- •Allergies to contrast agents;
- •Life expectancy of less than 12 months;
- •Participating in another drug or device research;
- •Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.
研究组 & 干预措施
WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system
Participants will be treated with WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system
干预措施: WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system (Device)
结局指标
主要结局
Rate of all-cause mortality and major stroke within 12 months after surgery
时间窗: 12 months after surgery
All-cause mortality includes cardiac mortality, non-cardiac mortality, and mortality from unknown causes. Severe stroke is defined as a modified Rankin score (mRS) ≥ 2 at 90 days following stroke onset.
次要结局
- Incidence of aortic covered stent graft displacement(6 months, 12 months after operation)
- Rate of immediate technical success following surgery(immediately after the surgery)
- Rate of aortic aneurysm progression under control(12 months after operation)
- Rate of major adverse events(30 days after surgery)
- Incidence of Type I or Type III endoleak(during operation and at 1, 6, and 12 months after operation)
- Postoperative branch vessel patency rate(1 month, 6 months, 12 months after operation)
- Rate of conversion to thoracotomy or secondary intervention(30 days, 6 months, and 12 months after operation)
- Rate of aortic aneurysm-related mortality(12 months after operation)
- Incidence of severe adverse events(30 days, 6 months, and 12 months after operation)
- Incidence of device-related adverse events(30 days, 6 months, and 12 months after operation)