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Stent-Graft device under scrutiny for aortic aneurysm and dissection repair

NCT ID NCT06507865

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study tracks the safety and effectiveness of the GORE® TAG® Thoracic Branch Endoprosthesis, a stent-graft device used to treat aortic arch and descending aorta conditions such as aneurysms, dissections, and transections. Researchers will follow about 155 patients who receive the device as part of standard care, monitoring outcomes like technical success, device-related complications, and survival. The goal is to gather real-world data on how well the device performs over the medium term.

What this could mean

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

Active substance
GORE® TAG® Thoracic Branch Endoprosthesis (a stent-graft device)
What this could lead to
If successful, this study could confirm that the device is a safe and effective long-term option for treating complex aortic conditions, potentially reducing the need for open surgery.
What could go wrong
This is an observational registry, not a controlled trial, so results may not prove cause and effect. Risks include stroke, spinal cord injury, device migration, or need for additional 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

About 155 people

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

Started

Feb 2025

Expected to finish

Mar 2029

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

Registry participants are derived from patients presenting with vascular disease that may benefit from the placement of an endovascular stent graft. The target registry population is patients who are treated with TBE at participating sites. Only patients who meet all the inclusion and none of the exclusion criteria will be included in the registry. The registry has been designed with broad eligibility criteria to optimize the visibility of overall registry device use. An integral requirement to the target subject population is that the decision to use a TBE product has been made prior to considering the patient for possible registry participation. The TBE registry population will be defined as a successful recipient of TBE at the end of the index procedure.

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: Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements Patient has been or is intended to be treated with an eligible registry device Patient is age ≥ 18 years at time of informed consent signature. Exclusion Criteria: Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures. Patient with exclusion criteria required by local law. Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.

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Conditions

The condition(s) this trial relates to.

Aneurysm aortic aneurysm Aortic Aneurysm, Thoracoabdominal Aortic Dissection thoracic aortic aneurysm

As listed by the trial registrant

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

Aneurysm Dissection, aortic Taa thoracoabdominal aortic aneurysm Thoracic aortic aneurysm Transection aorta

Contacts and locations

Locations

  • AOU Padova

    Padova, 35128, Italy

  • ASST Spedali Civili di Brescia

    Brescia, 25123, Italy

  • Amsterdam UMC

    Amsterdam, 1105 AZ, Netherlands

  • Azienda Ospedaliera "G. Brotzu"

    Cagliari, Italy

  • Evangelismos General Hospital

    Athens, 106 76, Greece

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132, Italy

  • Klinik für Gefäßmedizin, Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Germany

  • Laiko General hospital of Athens

    Athens, 11527, Greece

  • Medizinische Universität Wien

    Vienna, A-1090, Austria

  • Policlinico di Sant'Orsola

    Bologna, 40138, Italy

  • Radboud UMC

    Nijmegen, 6525 GA, Netherlands

  • Rigshospitalet University Hospital

    Copenhagen, 2100, Denmark

  • Skane University Hospital

    Malmö, 205 02, Sweden

  • St Mary's Hospital

    London, W2 1NY, United Kingdom

  • St Thomas' Hospital

    London, SE1 7EH, United Kingdom

  • University of Heidelberg

    Heidelberg, 69120, Germany

  • Universitätsklinikum Münster

    Münster, 48149, Germany

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105, Germany

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