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Stent graft tested for keeping kidney and gut arteries open during aneurysm repair

NCT ID NCT05143138

NEW Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are collecting real-world data on the GORE VIABAHN VBX balloon expandable endoprosthesis when doctors use it as a bridging stent with branched and fenestrated endografts to treat aortic aneurysms that involve the renal and mesenteric arteries. The registry includes adults who received this device during endovascular aneurysm repair. The main goal is to measure how many target vessels stay open without blockage or a procedure to restore flow at 12 months.

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 VBX balloon expandable endoprosthesis used as a bridging stent
What this could lead to
If the device performs well, doctors could have stronger evidence that this stent graft reliably keeps kidney and gut arteries open during minimally invasive aneurysm repair.
What could go wrong
This is a registry, not a randomized trial, so it cannot prove the device causes good outcomes. Results may not apply to all patients or centers, and the stent can still develop blockages or need repeat procedures.

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

259 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Mar 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 data about GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis used as a Bridging Stent in conjunction with a branched/fenestrated stent graft to allow endovascular aneurysm repair. Patients will be identified from hospital database.

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. Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched/fenestrated stent graft to allow endovascular aneurysm repair from 31 December 2021 until 01 January 2017 2. Age ≥18 years at the time of implant 3. Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at registry entry, unless a waiver was granted), according to local regulations. Exclusion Criteria: 1. Patient treated for ruptured aneurysm or who were otherwise hemodynamically unstable at the time of the procedure 2. Patient treated for acute or sub-acute dissection, \<90 days from onset of symptoms 3. Patient treated using physician-modified endovascular grafts 4. Patient intended to be treated with chimney, periscope, octopus, sandwich technique per the pre-treatment case plan 5. At the time of treatment, patient had known coagulation disorders including hypercoagulability that were not amenable to treatment 6. Patient was pregnant at the time of treatment. 7. Participation in another drug or device investigational study within one year of device implant, that can confound the registry endpoints. 8. Patient had known or suspected systemic infection (including treatment for mycotic aneurysm) at the time of implant.

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm thoracic aortic aneurysm

As listed by the trial registrant

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

Abdominal aortic aneurysm Thoracic aortic aneurysm

Contacts and locations

Locations

  • "Vita-Salute" San Raffaele University I.R.C.C.S Ospedale San Raffaele

    Milan, 20132, Italy

  • AMC, Meibergdreef 9

    Amsterdam, 1105, Netherlands

  • Aarhus University

    Aarhus, 8200, Denmark

  • Azienda Ospedaliera Complesso Ospedaliero San Giovanni Addolorata

    Roma, 00184, Italy

  • Azienda Ospedaliera Universitaria Policlinico Umberto I

    Roma, Italy

  • Haukeland Universitetssjukehus

    Bergen, 5021, Norway

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clínico Universitario San Cecilio

    Granada, 18016, Spain

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132, Italy

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Skane University Hospital

    Malmö, 214 28, Sweden

  • St. Olavs Hospital

    Trondheim, Norway

  • UNN Tromsø

    Tromsø, 9038, Norway

  • Uppsala University Hospital

    Uppsala, S-751 85, Sweden

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