Guo's Aortic Arch Reconstruction: The First in Man Study of WeFlow-Arch Modular Embedded Branch Stent Graft System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Rate of no major adverse events related to device or surgery
研究概览
简要总结
This study is the first in man study of WeFlow-Arch Module Embedded Aorta Arch Stent Graft System
详细描述
The WeFlow-Arch Moduler Embedded Aorta Arch Stent Graft System first in man study is a prospective, single center, single arm trial, which will enroll a total of 20 patients. The goal of this study is to evaluate the safety and efficacy of WeFlow-Arch Moduler Embedded Aorta Arch Stent Graft System in the treatment of patients with lesions of the aortic arch.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 85 years old；
- •Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, dissection and ulcers involving the aortic arch;
- •The length of the ascending aorta is greater than 4cm (from the junction of the aortic sinus tube to the proximal edge of the innominate artery)；
- •Ascending aorta diameter ≥24mm and ≤44mm；
- •The diameter of the iliac artery ≥7mm ；
- •The diameter of the innominate artery ≤24mm, and the length ≥20mm；
- •Patients able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.
排除标准
- •Patients with ascending aortic aneurysm, dissection, ulcer, hematoma；
- •Experienced systemic infection during past three months;
- •History of aortic valve repair or replacement；
- •History of aortic surgery or endovascular repair surgery；
- •Carotid artery is severely narrowed, calcified, clotted, twisted；
- •Right axillary artery is severely narrowed, calcified, thrombosis, twisted；
- •Heart transplant；
- •Suffered MI or stroke during past three months；
- •Class IV heart function (NYHA classification)；
- •Pregnant or breastfeeding；
- •Allergies to contrast agents；
- •Life expectancy less than 12 months。
结局指标
主要结局
Rate of no major adverse events related to device or surgery
时间窗: 30 days after surgery
Major adverse events related to device or surgery include: stroke, respiratory failure, pericardial tamponade, dissection or aneurysm rupture, paraplegia, stent occlusion, stent bend, stent displacement, thrombosis or rupture of the approach vessel, switch to open surgery, death, etc.
次要结局
- Technical success rate(immediately after the surgery)
- Adverse event rate within 12 months after surgery(12 months after surgery)
- Immediate surgery success rate(immediately after the surgery)
- The clinical success rate(12 months after the surgery)
- The incidence rate of secondary operations within 12 months after surgery(12 months after surgery)