GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study

W.L. Gore & Associates

Status: Completed

Conditions: Vascular Stent-Graft Stenosis

Treatments: Device: GORE® VIABAHN® Stent Graft

Study type: Observational

Funder types: Industry

Identifiers

NCT04429243

JPS 19-05: AVR PMS

Details and patient eligibility

About

This study will confirm the efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® stent graft (hereafter referred to as "Viabahn") for the treatment of patients with stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft.

Enrollment: 124 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Participants who developed stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft
• Participants who was used to repair vascular access circuits for purposes other than treatment of stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft

Trial design

124 participants in 1 patient group

GORE® VIABAHN® Stent Graft

Description:

Participants will be examined 1, 3, 6, 12 and 24 months following the GORE® VIABAHN® Stent Graft installation.

Treatment:

Device: GORE® VIABAHN® Stent Graft