A Prospective, Multicenter, Randomized, Controlled, Non-inferiority Clinical Trial to Evaluate the Safety and Efficacy of LineMatrix® Biological Vascular Graft for the Creation of Arteriovenous Graft
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 326
- 试验地点
- 12
- 主要终点
- Primary patency rate at 6 months postoperatively
研究概览
简要总结
The study is planned to be conducted at multiple centers, with an intended enrollment of 326 subjects. Protocol-eligible subjects will be randomized in a 1:1 ratio to either the investigational group or the control group. The investigational group will receive a Biological Vascular Graft(LineMatrix®) manufactured by Humatrix Medical Technology (Suzhou) Co., LTD, while the control group will receive an arteriovenous graft (GORE-INTERING®) manufactured by W.L. Gore & Associates, Inc. The primary endpoints are the Primary patency rate at 6 months postoperatively and the Cumulative Patency Rate at 12 Months postoperatively. Subjects will undergo follow-up during the screening period, at the time of AVG procedure, and at 1 month, 3 months, 6 months, and 12 months post-operatively. Safety and efficacy parameters will be observed and recorded during and after the surgery to evaluate the safety and effectiveness of the LineMatrix® Biological Vascular Graft for the creation of arteriovenous graft in patients with end-stage renal disease (ESRD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •(1) Age ≥18 years and ≤80 years, male or female;
- •(2) Diagnosed with end-stage renal disease (ESRD) requiring maintenance hemodialysis;
- •(3) Requiring establishment of a long-term hemodialysis vascular access but unable to have a autologous arteriovenous fistula (AVF) created;
- •(4) Assessed by the investigator as suitable for implantation of an arteriovenous graft (AVG) in the upper extremity;
- •(5) Able to understand the purpose of the study, voluntarily participating and providing signed informed consent(ICF), and willing to comply with all scheduled follow-up assessments.
排除标准
- •(1) Known or suspected history of allergy to heparin, alcohol, or bovine-derived products;
- •(2) Planned to undergo renal transplantation or transition to peritoneal dialysis within 1 year;
- •(3) Hemoglobin concentration <60 g/L, or platelet count <60 × 10⁹/L;
- •(4) Left ventricular ejection fraction (LVEF) <30%;
- •(5) Severe cardiac disease, including New York Heart Association (NYHA) Class III-IV severe heart failure, or history of myocardial infarction, unstable angina, or sustained ventricular tachyarrhythmia requiring continuous treatment within 6 months prior to enrollment;
- •(6) History of stroke within 1 month prior to enrollment;
- •(7) Uncontrolled or poorly controlled diabetes mellitus (preoperative glycated hemoglobin >10%);
- •(8) Immunodeficiency disorders, or current treatment with corticosteroids (prednisone-equivalent dose ≥10 mg) or immunosuppressive agents (e.g., sirolimus, mycophenolate mofetil, cyclosporine, cyclophosphamide, tacrolimus);
- •(9) Malignancy or other severe systemic disease with a life expectancy of <12 months;
- •(10) Heparin-induced thrombocytopenia type II (HIT-2) or other contraindications to heparin use;
- •(11) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 × upper limit of normal (ULN);
- •(12) Coagulation disorders (activated partial thromboplastin time [APTT] or prothrombin time [PT] >1.5 × ULN);
- •(13) Systemic or surgical site infection (white blood cell [WBC] count >15 × 10⁹/L);
- •(14) Baseline hypotension, or frequent hypotensive episodes within the past month (frequency ≥5 episodes/month, with hypotension defined as systolic blood pressure <90 mmHg or diastolic blood pressure <60 mmHg);
- •(15) Hypercoagulable state, or history of ≥2 episodes of deep vein thrombosis or peripheral vascular thrombosis not related to dialysis access;
- •(16) Known ipsilateral central venous stenosis, or clinical symptoms/signs suggestive of central venous stenosis confirmed by imaging;
- •(17) Severe mental disorders that preclude cooperation with the study protocol;
- •(18) Pregnant or lactating women, or women of childbearing potential who plan to conceive during the trial and are unwilling to use effective contraception;
- •(19) Currently enrolled in another drug or medical device clinical trial and not yet completed the study;
- •(20) Any other conditions that, in the investigator's opinion, make the patient unsuitable for participation in this clinical trial.
结局指标
主要结局
Primary patency rate at 6 months postoperatively
时间窗: 6 months
Primary Patency Rate is defined as the proportion of subjects who have not experienced any of the following events from the date of vascular access creation through 6 months post-operatively: thrombosis, or any intervention performed to promote, maintain, or re-establish patency (e.g., angioplasty).
Cumulative Patency Rate at 12 Months Postoperatively
时间窗: 12 months
Cumulative Patency Rate is defined as the proportion of subjects whose vascular access has not been abandoned from the date of vascular access creation through 12 months post-operatively.
次要结局
- Primary patency rate at 3,12 months postoperatively(3,12 months)
- Cumulative Patency Rate at 3,6 Months Postoperatively(3,6 months)
- Surgical success rate(30 days)
- Time to First Cannulation(12 months)
- Device Performance Evaluation(12 months)
研究者
Yaxue Shi
MD
Longhua Hospital