[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"arteriovenous-graft\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:arteriovenous-graft":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100652403","linematrix-biological-vascular-graft-for-the-creation-of-arteriovenous-graft-100652403",false,"NCT07773051","LineMatrix® Biological Vascular Graft for the Creation of Arteriovenous Graft","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","Inclusion Criteria:\n\n* (1) Age ≥18 years and ≤80 years, male or female;\n* (2) Diagnosed with end-stage renal disease (ESRD) requiring maintenance hemodialysis;\n* (3) Requiring establishment of a long-term hemodialysis vascular access but unable to have a autologous arteriovenous fistula (AVF) created;\n* (4) Assessed by the investigator as suitable for implantation of an arteriovenous graft (AVG) in the upper extremity;\n* (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.\n\nExclusion Criteria:\n\n* (1) Known or suspected history of allergy to heparin, alcohol, or bovine-derived products;\n* (2) Planned to undergo renal transplantation or transition to peritoneal dialysis within 1 year;\n* (3) Hemoglobin concentration \\\u003C60 g\u002FL, or platelet count \\\u003C60 × 10⁹\u002FL;\n* (4) Left ventricular ejection fraction (LVEF) \\\u003C30%;\n* (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;\n* (6) History of stroke within 1 month prior to enrollment;\n* (7) Uncontrolled or poorly controlled diabetes mellitus (preoperative glycated hemoglobin \\>10%);\n* (8) Immunodeficiency disorders, or current treatment with corticosteroids (prednisone-equivalent dose ≥10 mg) or immunosuppressive agents (e.g., sirolimus, mycophenolate mofetil, cyclosporine, cyclophosphamide, tacrolimus);\n* (9) Malignancy or other severe systemic disease with a life expectancy of \\\u003C12 months;\n* (10) Heparin-induced thrombocytopenia type II (HIT-2) or other contraindications to heparin use;\n* (11) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>2 × upper limit of normal (ULN);\n* (12) Coagulation disorders (activated partial thromboplastin time \\[APTT\\] or prothrombin time \\[PT\\] \\>1.5 × ULN);\n* (13) Systemic or surgical site infection (white blood cell \\[WBC\\] count \\>15 × 10⁹\u002FL);\n* (14) Baseline hypotension, or frequent hypotensive episodes within the past month (frequency ≥5 episodes\u002Fmonth, with hypotension defined as systolic blood pressure \\\u003C90 mmHg or diastolic blood pressure \\\u003C60 mmHg);\n* (15) Hypercoagulable state, or history of ≥2 episodes of deep vein thrombosis or peripheral vascular thrombosis not related to dialysis access;\n* (16) Known ipsilateral central venous stenosis, or clinical symptoms\u002Fsigns suggestive of central venous stenosis confirmed by imaging;\n* (17) Severe mental disorders that preclude cooperation with the study protocol;\n* (18) Pregnant or lactating women, or women of childbearing potential who plan to conceive during the trial and are unwilling to use effective contraception;\n* (19) Currently enrolled in another drug or medical device clinical trial and not yet completed the study;\n* (20) Any other conditions that, in the investigator's opinion, make the patient unsuitable for participation in this clinical trial.","ALL","18 Years","80 Years",{"count":20,"type":21},326,"ESTIMATED","INTERVENTIONAL",[24],"NA","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).",[27],"Arteriovenous Graft",[27,29,30],"Hemodialylsis","End Stage Kidney Disease(ESKD)","RECRUITING","2026-08-15",{"date":34,"type":35},"2026-08-19","ACTUAL",{"date":37,"type":35},"2025-08-25",{"date":39,"type":21},"2027-09-30",{"name":41,"class":42},"Longhua Hospital","OTHER",12]