Active — Not RecruitingNot Applicable

Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry

Belgium, France, Germany614 participantsStarted 2021-10-09

Plain-language summary

Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

Who can participate

Age range

18 Years

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

. Age ≥ 18 years
. Signed informed consent form
. Suitable for endovascular treatment with VSX based on treating physician's best medical judgment
. Willingness of the patient to adhere to institutional standard of care follow-up requirements

Exclusion criteria

. Non-compliant lesions where full expansion of an angioplasty balloon catheter is not achievable during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system.
. Use of the VSX Device in lesions involving a major side branch that may be covered by the endoprosthesis.
. Lesion(s) cannot be treated with available VSX Device sizes per current Instructions for Use (IFU).
. Lesion requires treatment with an altered endoprosthesis or delivery system. (Do not cut the endoprosthesis. The endoprosthesis should only be placed and deployed using the supplied catheter system).
. Previous or concurrent enrollment into this registry (e.g., previous enrollment into another treatment cohort or patient requires enrollment into more than one cohort) (Note: Only the first VSX treatment will be enrolled if concurrent VSX procedures are performed that would require enrollment into more than one cohort).

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

Freedom from Device-Related Serious Adverse Events (SAE)

Timeframe: 12 month

Trial details

NCT IDNCT04907240

SponsorW.L.Gore & Associates

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-10

View on ClinicalTrials.gov More Peripheral Artery Disease trials