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Clinical Trials in the Netherlands / NCT04246463
Recruiting Observational

Terumo Aortic Global Endovascular Registry

NCT04246463 · tracked via the Priya Life Science Netherlands tracker
Phase
Observational
Started
2019-12-17
Last updated
2026-03-13

Condition(s) studied

Abdominal Aortic AneurysmThoracic Aortic AneurysmSurgery

Investigational drug(s) / intervention(s)

ThoracicAbdominalCustom DeviceIlliac Artery

Thoracic: Implant of a Relay stent graft system

Abdominal: Implant with an Anaconda or Treo Stent graft system

Custom Device: Implant of a Fenestrated device such as Fenestrated Anaconda or Fenestrated TREO, Relay Branch or other customised device

Illiac Artery: Implant with an Anaconda Iliac leg only

Study summary

Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (58)

FacilityCityRegionStatus
Long Beach Memorial Medical Center Long Beach California Recruiting
University of Colorado Anschutz Medical Campus Aurora Colorado Recruiting
UC Health Memorial Hospital Center Colorado Springs Colorado Recruiting
Yale University New Haven Connecticut Recruiting
MedStar Washington Hospital Center Washington D.C. District of Columbia Recruiting
University of Florida Gainesville Florida Recruiting
Loyola University of Chicago (Loyola) Chicago Illinois Recruiting
Ascension St. Vincent Heart Center Indianapolis Indiana Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Cooper University Hospital Camden New Jersey Recruiting
University of Pennsylvania Philadelphia Pennsylvania Recruiting
University of Pittsburgh Pittsburgh Pennsylvania Recruiting
Ascension Texas Cardiovascular / UT Dell Medical School Austin Texas Recruiting
Baylor, Scott & White Health (BSW Health) Texas City Texas Recruiting
University of Utah Salt Lake City Utah Recruiting
University of Virgina Charlottesville Virginia Recruiting
Sentara Heart Hospital Norfolk Virginia Recruiting
Imeldaziekenhuis Bonheiden Belgium Recruiting
Clinques Uni. St Lucs Brussels Belgium Withdrawn
Hôpital Pneumologique et Cardiovasculaire Louis-Pradel Bron France Recruiting
CHU St Etienne Saint-Etienne France Recruiting
Klinikum Augsburg Augsburg Germany Recruiting
Evangelisches Krankenhaus Hubertus Berlin Germany Recruiting
Klinikum Chemnitz Chemnitz Germany Recruiting
University Heart Center Freiburg Freiburg im Breisgau Germany Recruiting
Aortic Center University Hospital Göttingen Germany Withdrawn
Bonifatius Hospital Lingen Germany Recruiting
St. Franziskus Hospital Münster Germany Recruiting
University Hospital Tübingen Tübingen Germany Recruiting
Policlinico Consorziale di Bari Bari Italy Recruiting
Compensorio Sanitario Bolzano Bolzano Italy Recruiting
Cagliari-Ospedale Brotzu Cagliari Italy Recruiting
Firenze Ospedale Careggi Careggi Italy Recruiting
Azienda Ospedaliera di Catania Catania Italy Recruiting
Uni. di Modena Modena Italy Not Yet Recruiting
Azienda Ospedaliera Universitaria Senese Siena Italy Recruiting
Maurizano Torino (turin) Turin Italy Recruiting
Turin Uni. Hospital Turin Italy Not Yet Recruiting
Vumc Amsterdam Amsterdam Netherlands Recruiting
Rijnstate Arnham Arnhem Netherlands Recruiting

+ 18 more sites — see the full list on the official registry below.

More Vascutek Ltd. trials in the Netherlands

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04246463 on ClinicalTrials.gov ↗ ← All trials in the Netherlands