Health TrialsbyHealthPanel

LineMatrix® Biological Vascular Graft for the Creation of Arteriovenous Graft

ConditionArteriovenous Graft
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLonghua Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(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;

Disqualifiers

(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%;

Trial design

Design model

Parallel

Treatments tested in this trial

  • LineMatrix® Biological Vascular Graft

    Device

    LineMatrix® Biological Vascular Graft

  • GORE-INTERING®

    Device

    GORE-INTERING®

Treatment groups

326 Participants
are divided into 2 treatment groups
Group A: LineMatrix® Biological vascular graftExperimental treatment 1 intervention
Group B: GORE-INTERING®Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary patency rate at 6 months postoperatively

Primary Patency Rate is defined as the proportion of subjects who have not experienced any of the following events from the date of vascular access creation through 6 months post-operatively: thrombosis, or any intervention performed to promote, maintain, or re-establish patency (e.g., angioplasty).

Time frame
6 months
2

Cumulative Patency Rate at 12 Months Postoperatively

Cumulative Patency Rate is defined as the proportion of subjects whose vascular access has not been abandoned from the date of vascular access creation through 12 months post-operatively.

Time frame
12 months

Secondary outcomes

1

Primary patency rate at 3,12 months postoperatively

Primary Patency Rate is defined as the proportion of subjects who have not experienced any of the following events from the date of vascular access creation through 3,12 months post-operatively: thrombosis, or any intervention performed to promote, maintain, or re-establish patency (e.g., angioplasty).

Time frame
3,12 months
2

Cumulative Patency Rate at 3,6 Months Postoperatively

Cumulative Patency Rate is defined as the proportion of subjects whose vascular access has not been abandoned from the date of vascular access creation through 3, 6 months post-operatively.

Time frame
3,6 months
3

Surgical success rate

Surgical success rate is defined as the successful completion of the arteriovenous graft (AVG) surgery using the investigational device, without any device-related serious adverse events occurring during the perioperative period.

Time frame
30 days
4

Time to First Cannulation

Time to First Cannulation is defined as the interval from the AVG procedure to the first hemodialysis session performed using the arteriovenous graft.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Longhua Hospital

Lead sponsor

Humatrix Medical Technology (Suzhou) Co., LTD

Collaborator

Source ClinicalTrials.gov
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