LineMatrix® Biological Vascular Graft for the Creation of Arteriovenous Graft

The study is planned to be conducted at multiple centers, with an intended enrollment of326 subjects. Protocol‐eligible subjects will be randomized in a 1:1 ratio to either theinvestigational group or the control group. The investigational group will receive aBiological 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 arethe Primary patency rate at 6 months postoperatively and the Cumulative Patency Rate at12 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 monthspost‐operatively. Safety and efficacy parameters will be observed and recorded during andafter the surgery to evaluate the safety and effectiveness of the LineMatrix® BiologicalVascular Graft for the creation of arteriovenous graft in patients with end‐stage renaldisease (ESRD).