Clinical Research Directory

LineMatrix® Biological Vascular Graft for the Creation of Arteriovenous Graft

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).

Optimizing Access Surgery In Senior Hemodialysis Patients

The number of elderly hemodialysis patients is growing. Vascular access complications are a major determinant of the quality of life and health care costs for these vulnerable patients. The three different types of vascular access, i.e. autologous arteriovenous fistulas, arteriovenous grafts, and central venous catheters, have never been compared in randomized controlled trials. This project will deliver the much-needed evidence to determine the optimal strategy for vascular access creation in elderly hemodialysis patients in order to deliver better health care at lower costs.