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New registry monitors VBX stent graft in Real-World use

NCT ID NCT03720704

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is a registry that collects safety and performance data on the GORE® VIABAHN® VBX Stent Graft when used in peripheral vessels. It involves 280 adults who need this device to treat peripheral vascular disease. The goal is to see how well the stent graft works and if there are any serious side effects within 30 days of the procedure.

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

280 people

The number who actually took part.

Started

Dec 2018

Expected to finish

Jul 2027

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

The registry has been designed with broad eligibility criteria to capture real-world VBX Stent Graft use, in multiple pathologies and in conditions needing preservation of peripheral vessels.

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: * Age ≥ 18 years. * Signed informed consent form * Endovascular indication for treatment based on treating physician's best medical judgment. * Intend for no other stents to be placed in the same peripheral vessel(s) targeted for VBX Stent Graft placement. * Willingness of the patient to adhere to standard of care follow-up requirements. Exclusion Criteria: * Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. * Participation in concurrent research study or registry which may confound registry results, unless approved by Gore. * Pregnant or breast-feeding female at time of informed consent signature. * Life expectancy \< 12 months due to comorbidities. * Use of the VBX Stent Graft is for the treatment of de novo iliac occlusive disease. * Use of the VBX Stent Graft is for the treatment of aortic coarctations. * Use of the VBX Stent Graft in the coronary, pulmonary, carotid, vertebral, isolated infrarenal aortic, or vena cava vessels.

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Conditions

The condition(s) this trial relates to.

peripheral vascular disease

As listed by the trial registrant

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

Peripheral vascular diseases

Contacts and locations

Locations

  • Azienda Ospedaliera Policlinico Sant'Orsola Malpighi

    Bologna, Italy

  • Azienda Ospedaliero-Universitaria di Padova

    Padova, Italy

  • Erasmus Medical Center

    Rotterdam, Netherlands

  • Fondazione Poliambulanza

    Brescia, Italy

  • Hospital Universitario Central de Asturias (HUCA)

    Oviedo, Spain

  • Hôpital Marie Lannelongue

    Paris, France

  • Ospedale di Circolo e Fondazione Macchi

    Varese, Italy

  • St. Franziskus Hospital

    Münster, Germany

  • University Hospital Heidelberg

    Heidelberg, Germany

  • University Hospital of Santiago de Compostela

    Santiago de Compostela, Spain

  • University Medical Center Groningen

    Groningen, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.