CompletedNot Applicable

GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study

Japan124 participantsStarted 2020-07-02

Plain-language summary

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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Subjects With Loss of Primary Patency of Target Lesion

Timeframe: up to 2 years

Number of Subjects With Loss of Secondary Patency of Target Lesion

Timeframe: up to 2 years

Number of Subjects With Loss of Primary Patency of Vascular Access Circuit

Timeframe: up to 2 years

Number of Subjects With Loss of Secondary Patency of Vascular Access Circuit

Timeframe: up to 2 years

Mean Cumulative Number of Re-treatment Per Target Lesion

Timeframe: at 24 months

Number of Subjects Achieving Technical Success

Timeframe: Day 1

Number of Subjects Achieving Clinical Success

Timeframe: Day 1 to Month 1 follow up

Trial details

NCT IDNCT04429243

SponsorW.L.Gore & Associates

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-10-06

Results submitted2024-07-08

View on ClinicalTrials.gov More Vascular Stent-Graft Stenosis trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Subjects With Loss of Primary Patency of Target Lesion

Timeframe: up to 2 years

Number of Subjects With Loss of Secondary Patency of Target Lesion

Timeframe: up to 2 years

Number of Subjects With Loss of Primary Patency of Vascular Access Circuit

Timeframe: up to 2 years

Number of Subjects With Loss of Secondary Patency of Vascular Access Circuit

Timeframe: up to 2 years

Mean Cumulative Number of Re-treatment Per Target Lesion

Timeframe: at 24 months

Number of Subjects Achieving Technical Success

Timeframe: Day 1

Number of Subjects Achieving Clinical Success

Timeframe: Day 1 to Month 1 follow up