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New registry tracks Stent-Graft safety in thousands of patients

NCT ID NCT04907240

Knowledge-focused Sponsor: W.L.Gore & Associates Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This study is tracking over 600 people who received the GORE VIABAHN stent-graft as part of their normal medical care for conditions like peripheral artery disease or aneurysms. Researchers are monitoring how often serious device-related problems occur. The goal is to see how safe the device is in real-world use, outside of controlled clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) (a stent-graft device)
What this could lead to
If successful, this registry will confirm the device's safety in everyday use, supporting its continued use for various vascular conditions.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove the device works better than alternatives. Results depend on routine care and may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 614 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

Oct 2035

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All consecutive patients presenting with an indication for endovascular repair of one of the eight indications (iliac, SFA, SFA ISR, VAA, PAA, Trauma/Injury, AV access and others) are eligible for screening for participation in the registry. Only patients who meet all inclusion and no exclusion criteria, and who consent to participate will be enrolled.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years 2. Signed informed consent form 3. Suitable for endovascular treatment with VSX based on treating physician's best medical judgment 4. Willingness of the patient to adhere to institutional standard of care follow-up requirements Exclusion Criteria: 1. 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. 2. Use of the VSX Device in lesions involving a major side branch that may be covered by the endoprosthesis. 3. Lesion(s) cannot be treated with available VSX Device sizes per current Instructions for Use (IFU). 4. 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). 5. 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). 6. Participation in concurrent research study or registry which may confound registry results, unless approved by Gore. 7. Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. 8. Unable to tolerate antiplatelet therapy. 9. Patient has a non-controllable allergy to contrast or the VSX Device components. 10. Pregnant or breast-feeding female at time of informed consent signature. 11. Life expectancy \< 12 months due to comorbidities. 12. Patient has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).

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Conditions

The condition(s) this trial relates to.

Accidental Injuries injury peripheral arterial disease Popliteal Artery Aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemodialysis access Peripheral artery disease Popliteal aneurysm Trauma injury Visceral artery aneurysms

Contacts and locations

Locations

  • Alvaro Cunqueiro Hospital

    Vigo, 36213, Spain

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

    Ancona, 60127, Italy

  • Cardioangiologisches Centrum Bethanien

    Frankfurt, 60389, Germany

  • Centre Hospitalier Regional Universitaire de Brest

    Brest, 29200, France

  • Centre Hospitalier Unversitaire d'Angers

    Angers, 49933, France

  • Clinique RHENA

    Strasbourg, 67000, France

  • Dipartimento di Scienze Chirurgiche e Morfologiche

    Varese, 21100, Italy

  • Fondazione Poliambulanza

    Brescia, 25124, Italy

  • Greater Glasgow Health Board

    Glasgow, G12 0XH, United Kingdom

  • Hopital Edouard Herriot (HCL)

    Lyon, 69002, France

  • Hospital Paris Saint-Joseph

    Paris, 75014, France

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916, Spain

  • Karolinska University Hospital

    Solna, 171 64, Sweden

  • Krankenhaus Reinbek St. Adolf-Stift

    Reinbek, 21465, Germany

  • Marien Krankenhaus

    Hamburg, 22087, Germany

  • Medical Center Leeuwarden

    Leeuwarden, 8934 AD, Netherlands

  • Ospedale San Giovanni Molinette

    Torino, 10126, Italy

  • Papageorgiou Hospital

    Pávlos, 564 29, Greece

  • Queen Elizabeth Hospital

    London, SE18 4QH, United Kingdom

  • Rijnstate

    Arnhem, 6800 TA, Netherlands

  • S.C. Chirurgia Vascolare dell'A.O.U. di Modena

    Modena, 41124, Italy

  • Skane University Hospital

    Malmö, SE-205 02, Sweden

  • Southmead Hospital

    Bristol, BS10 5NB, United Kingdom

  • University Hospital Tuebingen

    Tübingen, 72076, Germany

  • University of Heidelberg

    Heidelberg, D-69120, Germany

  • iD3 Medical cvba

    Sint-Agatha-Berchem, 1082, Belgium

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