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Can Real-World data improve vascular surgery outcomes?

NCT ID NCT04545502

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study is a large registry that collects safety and performance data on Terumo Aortic knitted and woven grafts and cardiovascular patches used in standard clinical practice. It will include about 2,000 patients who need these devices to repair or bypass damaged blood vessels, such as those with aneurysms or dissections. The goal is to track outcomes like operative death, graft leakage, and the need for reintervention to better understand how these devices perform in real-world settings.

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 knitted and woven grafts, and cardiovascular patches (devices used to repair or bypass damaged blood vessels)
What this could lead to
If successful, this registry could provide real-world evidence on the safety and performance of these vascular devices, helping guide future treatment decisions and improve patient outcomes.
What could go wrong
As an observational registry, it cannot prove cause and effect. Results may be affected by variations in patient care and reporting across centers, and the devices are already on the market, so no new treatment is being tested.

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 2,000 people

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

Started

Feb 2021

Expected to finish

Jan 2037

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

Patients who require treatment, or have already received treatment within the last 5 years, with the following commercially available Terumo Aortic knitted and woven grafts and cardiovascular patches: * Gelsoft Plus - Straights and Bifurcated * Gelsoft Plus - Extra-Anatomical * Cardiovascular Patches - Gelseal, Gelsoft and Thin Wall * Gelweave - Abdominal, Thoracic and Thoracoabdominal * Gelweave - Valsalva This is a non-interventional study and therefore only patients who would normally receive treatment with a Terumo Aortic devices as part of standard treatment at the participating institution can 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: * Patients must meet all of the following inclusion criteria in order to be eligible for inclusion in the study: All Patients: * Patient meets the minimum age as per local regulations at time of consent * Patient requires treatment with study device(s) according to the IFU(s) * Patient is willing and able to comply with all SOC procedures and study visits * Patient or their legally authorised representative (LAR) has given written informed consent to participate in study, including consent to collect data retrospectively * For prospective emergency patients, retrospective consent is permissible * For retrospective patients who are deceased at time of enrollment, local EC regulations relating to consent process should be followed. Retrospective Patients only: * Patient has a minimum of 1 year post-operative follow-up data available, or complete data to death. * Patient implant date is no more than 5 years prior to study start date. Exclusion Criteria: * Any patient who meets any of the following exclusion criteria will be excluded from participation in the study: * Patient is unable or unwilling to comply with the SOC procedures or follow-up regime * Patient is contraindicated per the device IFU * Patient has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post-procedure

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Conditions

The condition(s) this trial relates to.

Aneurysm aortic disorder Aortic Root Aneurysm Carotid Artery Injuries Dissection, Ascending Aorta peripheral vascular disease

As listed by the trial registrant

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

Aneurysm Aortic arch Aortic diseases Aortic root aneurysm Aortic root dissection Bypass extremity graft Carotid artery injuries Dissection Occlusive vascular disease

How to take part

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

  1. The places running it

    26 sites in 4 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

  • AZ Groeninge Kortrijk

    RECRUITING

    Kortrijk, 8500, Belgium

  • Amphia Hospital (Ziekenhuis) Breda

    ACTIVE_NOT_RECRUITING

    Breda, 4818, Netherlands

  • CHU Bordeaux

    WITHDRAWN

    Bordeaux, France

  • CHU Clermont Ferrand

    RECRUITING

    Clermont-Ferrand, France

  • CHU de Dijon

    RECRUITING

    Dijon, France

  • CHU de Lille

    RECRUITING

    Lille, 59000, France

  • CHU de Rennes

    WITHDRAWN

    Rennes, 35033, France

  • CHU de Toulouse - Hôpital Rangueil

    RECRUITING

    Toulouse, 31059, France

  • Charité Berlin

    RECRUITING

    Berlin, 12200, Germany

  • Duke University

    RECRUITING

    Durham, North Carolina, 27705, United States

  • East Carolina University

    RECRUITING

    Greenville, North Carolina, 27858, United States

  • Heart Center Leipzig

    RECRUITING

    Leipzig, Germany

  • Hôpital Nord Marseille

    RECRUITING

    Marseille, 13015, France

  • Hôpitaux Universitaires de Strasbourg - Hôpital Civil

    RECRUITING

    Strasbourg, 67091, France

  • Indiana University Health

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Lehigh Valley Hospital

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

  • Ludwig-Maximilian Universität (LMU) Klinikum

    RECRUITING

    Munich, 81377, Germany

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Semmelweis University Heart and Vascular Center

    COMPLETED

    Budapest, Budapest, 1122, Hungary

  • UKE Hamburg

    RECRUITING

    Hamburg, 20251, Germany

  • UNIVERSITÄTSKLINIKUM FREIBURG/Bad Krozingen

    RECRUITING

    Freiburg im Breisgau, Germany

  • UZ Gent

    RECRUITING

    Ghent, 9000, Belgium

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Uniklinik Bonn

    RECRUITING

    Bonn, 53127, Germany

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Colorado Anschutz

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19105, United States

  • University of South Florida - Tampa General

    RECRUITING

    Tampa, Florida, 33620, United States

  • Universitätsmedizin Mainz (University Hospital Mainz)

    RECRUITING

    Mainz, 55131, Germany

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23298, United States

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