NCT05754541招募中不适用
Guo's Endovascular Aortic Arch Replacement of Aortic Dissection by WeFlow-Tribranch Endoprothesis: a Multicenter Pilot Study(Graft Study)
Hangzhou Endonom Medtech Co., Ltd.4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年11月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- All-cause mortality and major stroke within 12 months after surgery.
研究概览
简要总结
To explore the effect and prognosis of endovascular interventional therapy in high-risk patients with aortic arch dissection and aneurysm
详细描述
The WeFlow-Tribranch Aortic Arch Stent Graft System first in man study is a prospective, multi-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-Tribranch Aortic Arch Stent Graft System in the treatment of patients with aortic arch dissection and 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
- •Patients aged 18 to 80 years old.
- •The patient was diagnosed with subacute or chronic aortic arch dissection, or Aortic arch aneurysms.
- •Patients 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;
- •Innominate artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
- •Left common carotid artery or left subclavian artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
- •Suitable arterial access for endovascular interventional treatment ;
- •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.
- •Patients evaluated by at least two vascular surgeons or cardiac surgeons as high surgical risk patients or deemed to have significant surgical contraindications. (The recommended reference criteria are: EuroSCORE score ≥ 6, or CFS score > 4, or ASA grade 3-4, or there are other high-risk surgical factors that affect the prognosis of the subject, such as patients with a history of open surgery, other high-risk factors judged by a physician team, or patients who refuse open surgery.)
排除标准
- •Patients that have experienced systemic infection during past three months;
- •Neck surgery was performed within three months;
- •Infectious aortic disease、Takayasu arteritis，Marfan syndrome (or other connective tissue diseases );
- •Patients with severe stenosis, calcification, thrombosis or tortuosity of the Brachiocephalic trunk, Left common carotid artery or left subclavian artery;
- •Heart transplant patients;
- •Patients that have suffered MI or stroke during past three months;
- •Patients with Class IV heart function (NYHA classification) or LVEF<30%
- •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); thrombocytopenia (PLT count < 50 × 109/L);
- •Patients with renal insufficiency， serum creatinine > 150 umol/l (or 3.0 mg/dl) and / or end-stage renal disease requiring renal dialysis shall be determined by the investigator after comprehensive analysis;
- •Subjects with severe liver dysfunction and ALT or AST exceeding 3 times the upper limit of normal; Subjects whose serum total bilirubin (STB) exceeds 2 times the upper limit of normal;
- •Patients with intestinal necrosis and lower limb ischemic necrosis;
- •Paraplegic patients;
- •Patients that are pregnant or breastfeeding;
- •Patients with allergies to contrast agents;
- •Patients with a life expectancy of less than 12 months;
- •Patients currently participating in other drug or device research;
- •Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.
结局指标
主要结局
All-cause mortality and major stroke within 12 months after surgery.
时间窗: 12 months post-intervention
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
- Major adverse events occurring within 30 days after surgery.(within 30 days after surgery)
- Incidence of severe adverse events.(within 12 months post-intervention)
- Aortic remodeling results.(1 month, 6 months and 12 months post-intervention)
- Aortic-related mortality within 12 months post operation.(within 12 months post operation)
研究者
研究点 (4)
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