Completed

GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study - Treatment of Patients With Stenosis or Occlusion at the Venous Anastomosis of Synthetic Arteriovenous (AV) Access Graft

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: July 2020
See protocol details

Summary

Principal SponsorW.L.Gore & Associates
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 2, 2020

Actual date on which the first participant was enrolled.

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.

Official TitleGORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study - Treatment of Patients With Stenosis or Occlusion at the Venous Anastomosis of Synthetic Arteriovenous (AV) Access Graft
NCT04429243
Principal SponsorW.L.Gore & Associates
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

124 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 17 locations

Suspended

Kaikoukai Central Clinic

Nagoya, JapanOpen Kaikoukai Central Clinic in Google Maps
Suspended

Nagoya Vascular Access Clinic

Nagoya, Japan
Suspended

Matsuyama Red Cross Hospital

Matsuyama, Japan
Suspended

Kansai Rosai Hospital

Amagasaki, Japan
Completed17 Study Centers