Guo's visceRal artEries Reconstruction :The Prospective, Multiple Center, Objective Performance Criteria Clinical Trial About the sAfTy and Efficacy of WeFlow-JAAATM Stent Graft System.(GREAT Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Rate of no major adverse events occurred within 30 days after operation
研究概览
简要总结
A prospective, multi-center, objective performance criteria clinical trial to evaluate the safety and efficacy of WeFlow-JAAA stent graft system manufactured by Hangzhou Endonom Medtech Co., Ltd. for the complex abdominal aortic aneurysm.
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 18-80 years old, regardless of gender;
- •Subjects who were diagnosed with Juxtarenal and Pararenal abdominal aortic aneurysms and needed to reconstruct the blood supply of superior mesenteric artery and bilateral renal arteries;
- •Have appropriate vascular conditions, mainly including:
- •The distance between the upper edge of the aneurysm and the lower edge of the opening of superior mesenteric artery ≥ 4mm;
- •The angle between the proximal aneurysm neck and the aortic long axis near the opening of superior mesenteric artery ≤ 60 ° ;
- •The aortic diameter at the opening of superior mesenteric artery ranges from 18 to 34 mm ；
- •The diameter range of the starting part of superior mesenteric artery is 5-12mm；
- •The diameter range of the initial part of bilateral renal arteries is 4.5-10mm;
- •Length of non bifurcated segment of superior mesenteric artery and renal artery ≥ 10mm;
- •Blood vessel diameter at the bifurcation of abdominal aorta ≥ 16mm；
- •The length of distal anchoring area of iliac artery ≥ 15mm;
- •The diameter range of distal anchoring area of iliac artery is 8-24mm;
- •With appropriate femoral artery、iliac artery and upper limb artery approaches, endovascular treatment can be performed.
- •Those who can understand the purpose of the trial, voluntarily participate in the study, sign the informed consent form by themselves or their legal representative, and are willing to complete the follow-up according to the protocol requirements.
排除标准
- •Patients with ruptured abdominal aortic aneurysm, pseudoaortic aneurysm and dissecting aortic aneurysm with hemodynamic instability;
- •Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue diseases);
- •Severe stenosis, calcification and mural thrombosis in the proximal anchoring area of the stent;
- •Other vascular diseases need to be intervened in the same operation (such as coronary artery and carotid artery) and the postoperative drug treatment scheme is affected;
- •There is a history of myocardial infarction, TIA or cerebral infarction in recent 3 months;
- •The subject has a history of abdominal aortic surgery or endovascular repair;
- •Patients with severe liver, kidney, lung and cardiac dysfunction before operation [subjects with serum creatinine level > 150umol / L; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper normal limit; total serum bilirubin (STB) subjects who exceed 2 times the upper limit of normal; subjects whose left ventricular ejection fraction is less than 50% by color Doppler echocardiography.];
- •Patients with acute systemic infection;
- •Patients with contraindications to antiplatelet agents and anticoagulants;
- •Subjects are allergic to contrast agents, anesthetics, stents and conveyor materials;
- •Subjects cannot tolerate anesthesia;
- •Subjects Women who are pregnant or lactating or who cannot use contraception during the trial;
- •Subjects whose life expectancy is less than 12 months (such as advanced malignant tumor);
- •Subjects have participated in clinical trials of other drugs or devices in the same period;
- •The researchers determine that the subjects' vascular conditions affect the revascularization of branch arteries or are combined with other diseases and are not suitable to participate in this study.
研究组 & 干预措施
WeFlow-JAAA Stent Graft System
干预措施: WeFlow-JAAA Stent Graft System (Device)
结局指标
主要结局
Rate of no major adverse events occurred within 30 days after operation
时间窗: Within 30th day after operation
The main adverse events within 30 days after operation refer to all-cause death, myocardial infarction, renal failure, respiratory failure, ischemic stroke, intestinal necrosis, severe ischemia or necrosis of lower limbs and paraplegia within 30 days after operation. Among them, renal failure leads to lasting dialysis, renal transplantation or other fatal results. Respiratory failure leads to significantly prolonged intubation time, tracheotomy, deterioration of pulmonary function or other fatal results. Intestinal necrosis refers to intestinal ischemia that requires intestinal resection or leads to other fatal results. Severe ischemia of lower limbs refers to new severe claudication or resting pain after operation.
The success rate of treatment of abdominal aortic aneurysm 12 months after operation
时间窗: 12 months after operation
Immediate postoperative technical success refers to the successful delivery of the conveyor of aortic and branch covered stents to the predetermined position, the accurate positioning and successful deployment of the stent, and the conveyor can be safely withdrawn from the body. At the end of the operation, there is no type I and III endoleak and the branch stent is unobstructed.
次要结局
- Rate of all cause mortality(Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation)
- Rate of abdominal aortic aneurysm related mortality(Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation)
- Incidence of aortic covered stent displacement(6 and 12 months after operation)
- Incidence of serious adverse events(Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation)
- Incidence of type I or type III internal leakage(Intraoperative, before discharge, 6 months, 12 months)
- Incidence of device related adverse events(Before discharge, 30 days, 6 months, 12 months and 2-5 years after operation)
- Incidence of conversion to open surgery or secondary interventional surgery for abdominal aortic aneurysm(Before discharge, 6 months, 12 months, 2 ~ 5 years)
- Patency rate of postoperative branches(Before discharge, 6 months, 12 months)
- Incidence of type I or type III endoleak(Intraoperative, before discharge, 6 months, 12 months)