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LineMatrix® Biological Vascular Graft for the Creation of Arteriovenous Graft

NCT07773051 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2026-08-19

No results posted yet for this study

Summary

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).

Conditions

  • Arteriovenous Graft

Interventions

DEVICE

LineMatrix® Biological Vascular Graft

LineMatrix® Biological Vascular Graft

DEVICE

GORE-INTERING®

GORE-INTERING®

Sponsors & Collaborators

  • Humatrix Medical Technology (Suzhou) Co., LTD

    collaborator UNKNOWN

  • Longhua Hospital

    lead OTHER

Principal Investigators

  • Yaxue Shi · Longhua Hospital

  • Hua Li · Sir Run Run Shaw Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2027-06-30
Completion
2027-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07773051 on ClinicalTrials.gov