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Aortic graft registry aims to confirm device safety in 1,000 patients

NCT ID NCT04246463

Disease control Sponsor: Vascutek Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is tracking 1,000 people who receive Terumo aortic stent grafts to repair aneurysms in the abdomen or chest. Researchers are monitoring how well the devices work and any complications, like death related to the aorta. It is an observational registry, meaning no new treatment is being tested—just real-world data collection.

What this could mean

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

Active substance
Terumo Aortic endovascular stent grafts (devices)
What this could lead to
If successful, this registry will confirm that these grafts are safe and effective for treating aortic aneurysms, supporting their continued use.
What could go wrong
This is an observational registry, not a controlled trial, so results may be influenced by patient differences. Risks include device-related complications like rupture or need for reintervention.

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 1,000 people

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

Started

Dec 2019

Expected to finish

Nov 2030

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

US ONLY:TEVAR patients treated with a RelayPro Device. Patients requiring urgent or elective endovascular treatment of thoracic aortic aneurysm, pseudoaneurysm, dissection, PAU, transection or IMH. OUS: TEVAR- Patients requiring urgent/elective endovascular treatment of thoracic aortic aneurysm, pseudoaneurysm, dissection, PAU or IMH. Abdominal - EVAR Patients requiring urgent/elective endovascular treatment of infrarenal abdominal aortic aneurysm. Custom Device - FEVAR Patients with a documented thoracic/abdominal pathology suitable for elective treatment using a custom Terumo endovascular device. Ascending/Type A Dissections. Other- Isolated Iliac Artery Aneurysm .Patients requiring urgent or elective endovascular treatment of isolated Iliac Artery Aneurysms. As new indications/devices are approved those may also be captured.

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: * Minimum age as per local regulations * Indication for aortic endovascular repair with an approved or CE marked by a Regulatory body or custom-made Terumo Aortic Endovascular graft * Ability to provide informed consent o Emergent cases (typically younger patients with traumatic injuries) are not excluded if there is IRB/EC agreement to allow consent after intervention (i.e. consent to study participation, not to treatment) or use of a Legally Authorized Representative (LAR). * Willingness to comply with the registry protocol * Willingness to adhere to follow-up visits Note: Patients currently enrolled and actively participating within the TREO registry (IP-0020-16) can have their data migrated from TREO to the TiGER registry where local EC approval has been obtained and the patient has been reconsented to TiGER for longer follow-up. Exclusion Criteria: Patient is unable or unwilling to comply with the study follow-up regime. Patient is contraindicated per the IFU, or has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving treatment as well as the procedures and evaluations pre and post procedure.

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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 Surgery Thoracic aortic aneurysm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    54 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aortic Center University Hospital

    WITHDRAWN

    Göttingen, Germany

  • Ascension St. Vincent Heart Center

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Ascension Texas Cardiovascular / UT Dell Medical School

    RECRUITING

    Austin, Texas, 78705, United States

  • Azienda Ospedaliera Universitaria Senese

    RECRUITING

    Siena, Italy

  • Azienda Ospedaliera di Catania

    RECRUITING

    Catania, Italy

  • Baylor, Scott & White Health (BSW Health)

    RECRUITING

    Texas City, Texas, 75093, United States

  • Bonifatius Hospital

    RECRUITING

    Lingen, Germany

  • CHU Sao Joao

    WITHDRAWN

    Porto, Portugal

  • CHU St Etienne

    RECRUITING

    Saint-Etienne, France

  • Cagliari-Ospedale Brotzu

    RECRUITING

    Cagliari, Italy

  • Centro Hospital Uni Lisboa Norte

    RECRUITING

    Lisbon, Portugal

  • Civico, Ospedale Regionale

    WITHDRAWN

    Lugano, Switzerland

  • Clinques Uni. St Lucs

    WITHDRAWN

    Brussels, Belgium

  • Compensorio Sanitario Bolzano

    RECRUITING

    Bolzano, Italy

  • Cooper University Hospital

    RECRUITING

    Camden, New Jersey, 08103, United States

  • Diakonessenhuis

    RECRUITING

    Utrecht, Netherlands

  • Erasmus University Medical Center

    RECRUITING

    Rotterdam, Netherlands

  • Evangelisches Krankenhaus Hubertus

    RECRUITING

    Berlin, Germany

  • Firenze Ospedale Careggi

    RECRUITING

    Careggi, Italy

  • Hospital Clinic i Provincial de Barcelona

    RECRUITING

    Barcelona, Spain

  • Hospital Universitari Germans

    RECRUITING

    Badalona, Spain

  • Hospital Universitari Valle Hebrón de Barcelona

    RECRUITING

    Barcelona, Spain

  • Hospital Universitario Central de Asturias, Oviedo

    RECRUITING

    Oviedo, Spain

  • Hospital de Santa Marta

    RECRUITING

    Lisbon, Portugal

  • Hull Royal Infirmary

    RECRUITING

    Hull, United Kingdom

  • Hôpital Pneumologique et Cardiovasculaire Louis-Pradel

    RECRUITING

    Bron, France

  • Imeldaziekenhuis

    RECRUITING

    Bonheiden, Belgium

  • Klinikum Augsburg

    RECRUITING

    Augsburg, Germany

  • Klinikum Chemnitz

    RECRUITING

    Chemnitz, Germany

  • Long Beach Memorial Medical Center

    RECRUITING

    Long Beach, California, 90806, United States

  • Loyola University of Chicago (Loyola)

    RECRUITING

    Chicago, Illinois, 60153, United States

  • Luzerner Kantonsspital

    RECRUITING

    Lucerne, Switzerland

  • Manchester Royal Infirmary

    RECRUITING

    Manchester, United Kingdom

  • Maurizano Torino (turin)

    RECRUITING

    Turin, Italy

  • MedStar Washington Hospital Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Medisch Spectrum Twente

    RECRUITING

    Enschede, Netherlands

  • Oxford University Hospital

    RECRUITING

    Oxford, United Kingdom

  • Policlinico Consorziale di Bari

    RECRUITING

    Bari, Italy

  • Rijnstate Arnham

    RECRUITING

    Arnhem, Netherlands

  • Royal Derby Hospital

    NOT_YET_RECRUITING

    Derby, United Kingdom

  • Sentara Heart Hospital

    RECRUITING

    Norfolk, Virginia, 22042, United States

  • St. Antonius Ziekenhuis

    NOT_YET_RECRUITING

    Nieuwegein, 3430, Netherlands

  • St. Franziskus Hospital

    RECRUITING

    Münster, Germany

  • Turin Uni. Hospital

    NOT_YET_RECRUITING

    Turin, Italy

  • UC Health Memorial Hospital Center

    RECRUITING

    Colorado Springs, Colorado, 80909, United States

  • UMC Gronigen

    RECRUITING

    Groningen, Netherlands

  • Uni. di Modena

    NOT_YET_RECRUITING

    Modena, Italy

  • University Heart Center Freiburg

    RECRUITING

    Freiburg im Breisgau, Germany

  • University Hospital Tübingen

    RECRUITING

    Tübingen, Germany

  • University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • University of Virgina

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Vumc Amsterdam

    RECRUITING

    Amsterdam, Netherlands

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06520, United States

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