LineMatrix® Biological Vascular Graft for the Creation of Arteriovenous Graft
Recruiting · NCT07773051 · Interventional (participants receive a specific treatment) · Lead sponsor: Longhua Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Inclusion criteria
- (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.
Exclusion criteria
- (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.
Where it is running
12 locations listed.
- Beijing Haidian Hospital - Beijing, Beijing Municipality, China
- The First Affiliated Hospital of Chongqing Medical University - Chongqing, Chongqing Municipality, China
- South China Hospital of Shenzhen University - Shenzhen, Guangdong, China
- The First Hospital of Hebei Medical University - Shijiazhuang, Hebei, China
- The First Affiliated Hospital of Zhengzhou University - Zhengzhou, Henan, China
- Tongji Hospital Affiliated to Tongji Medical Collage of Huazhong University of Science and Technology - Wuhan, Hubei, China
- The Second Affiliated Hospital of Nanjing Medical University - Nanjing, Jiangsu, China
- The First Affiliated Hospital of Nanchang University - Nanchang, Jiangxi, China
- Longhua Hospital Shanghai University of Traditional Chinese Medicine - Shanghai, Shanghai Municipality, China
- The First Affiliated Hospital of Xi'an Jiaotong University - Xi’an, Shanxi, China
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - Hangzhou, Zhejiang, China
- The FIrst Affiliated Hospital, College of Medicine, Zhejiang University - Hangzhou, Zhejiang, China