Guo's Subclavian Artery Reconstruction: The Prospective, Multiple Center Study of WeFlow-Tbranch Stent Graft System(GUEST Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 29
- 主要终点
- Rate of no major adverse events within 30 days after surgery.
研究概览
简要总结
This study is a prospective, multiple center study to evaluate the safety and effectiveness of WeFlow-Tbranch single embedded branch thoracic aorta stent graft system manufactured by EndoNom Medtech (Hangzhou) Co., Ltd.
详细描述
This study is a prospective, multiple center study to evaluate the safety and effectiveness of WeFlow-Tbranch single embedded branch thoracic aorta stent graft system in the treatment of Stanford type B dissection of the proximal left subclavian artery. It is expected to complete the implantation of 120 patients in 29 centers within 12 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 24 months postoperatively, 36 months postoperatively, 48 months postoperatively and 60 months 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, no gender limitation;
- •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;
- •Diagnosed as Stanford type B aortic dissection and needed reconstruction of the left subclavian artery;
- •The diameter of the proximal anchoring area (the aorta at the posterior edge of the left common carotid artery) range: 18～42mm;
- •The length of the proximal anchoring area (the distance from the rear edge of the left common carotid artery opening to the first breach) ≥15mm;
- •The distance between the left common carotid artery and the left subclavian artery ≥5mm;
- •The distance between the left vertebral artery and the opening of the left subclavian artery is ≥15mm, the diameter of the starting part of the left subclavian artery is 6～20mm
- •With proper femoral artery, iliac artery, and brachial artery access, endovascular treatment of the aorta can be performed.
排除标准
- •Pregnant, breastfeeding or cannot contraception during the trial period;
- •Participated in clinical trials of other drugs or devices during the same period;
- •The same operation requires intervention in other vascular diseases (such as coronary artery, renal artery, superior mesenteric artery, etc.), and the postoperative drug treatment plan is therefore affected;
- •Allergic to contrast agents, anesthetics, patches, and delivery materials;
- •Cannot tolerate anesthesia;
- •Severe liver, kidney, lung, and heart function abnormalities before surgery [Serum creatinine exceeds 2 times the upper limit of normal; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper limit of normal; Serum total bilirubin (STB) more than 2 times the upper limit of normal; Left ventricular ejection fraction is lower than normal by cardiac color Doppler ultrasound examination];
- •True/false thoracic aortic aneurysm
- •History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
- •Contraindications to antiplatelet drugs and anticoagulants
- •Life expectancy is less than 12 months (such as advanced malignant tumors)
- •Acute systemic infection
- •Severe stenosis or calcification in the anchoring area at the proximal end of the stent, easily lead to the stent graft difficult adherent
- •Investigator judged that not suitable for interventional treatment.
结局指标
主要结局
Rate of no major adverse events within 30 days after surgery.
时间窗: 30 days after operation
Major adverse events within 30 days after operation refer to all-cause death, myocardial infarction, ischemic stroke, respiratory failure, liver failure, renal failure, intestinal necrosis, paraplegia, and amputation within 30 days after operation. Among them, renal failure refers to long-lasting dialysis, kidney transplantation, or other fatal results. Intestinal necrosis is intestinal ischemia that requires bowel resection or other fatal consequences. Severe lower limb ischemia refers to new severe limp or resting pain after surgery.
Treatment success rate of aortic dissection 12 months after operation
时间窗: 12 months after operation
The success rate of aortic dissection treatment at 12 months is a composite index, including immediate technical success after surgery and no displacement of the aorta and branch stent grafts in CTA 12 months after surgery, and no type I and type III endoleaks, the branch stent was unobstructed, and no second surgical intervention occurred during the follow-up period.
次要结局
- Success rate of remodeling of aortic dissection(30 days, 6 months, 12 months after surgery)
- Incidence of displacement of aorta and branch stent graft(6 months and 12 months after surgery)
- All-cause mortality, aortic dissection-related mortality, serious adverse events, device-related adverse events, incidence of left upper limb ischemia.(30 days, 6 months, and 12 months after operation)
- The incidence of type I or type III endoleaks(during operation, 30 days after operation, 6 months, 12 months)
- Postoperative branch vessel patency rate(30 days, 6 months, 12 months after surgery)
- Incidence of conversion to thoracotomy or secondary interventional surgery due to aortic dissection(immediately after the surgery, 30 days after operation, 6 months, 12 months, 2~5 years)