Terumo Aortic Global Endovascular Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thoracic, Abdominal, Custom Device, Illiac Artery.
- Who it may be relevant to
- Registry conditions: Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm, Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, France, Germany, Italy +5
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts
Overview
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.
Detailed description
Post Market registry collecting real world, post-approval safety, performance, patient reported outcomes and health economic data on patients treated with Terumo Aortic endovascular stent-grafts in standard clinical practice.
Interventions
- Device Thoracic
Implant of a Relay stent graft system - Device Abdominal
Implant with an Anaconda or Treo Stent graft system - Device Custom Device
Implant of a Fenestrated device such as Fenestrated Anaconda or Fenestrated TREO, Relay Branch or other customised device - Device Illiac Artery
Implant with an Anaconda Iliac leg only
Primary outcome measures
- Aortic Related Mortality [Time frame: 30 days post implant]
Secondary outcome measures (3)
- Technical Success [Time frame: Day 0]
- Composite Clinical Success [Time frame: 1 year]
- Additional Endpoints [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 17 centers
- Long Beach Memorial Medical Center — Long Beach
- University of Colorado Anschutz Medical Campus — Aurora
- UC Health Memorial Hospital Center — Colorado Springs
- Yale University — New Haven
- MedStar Washington Hospital Center — Washington D.C.
- University of Florida — Gainesville
- Loyola University of Chicago (Loyola) — Chicago
- Ascension St. Vincent Heart Center — Indianapolis
- … and 9 more centers
Italy · 9 centers
- Policlinico Consorziale di Bari — Bari
- Compensorio Sanitario Bolzano — Bolzano
- Cagliari-Ospedale Brotzu — Cagliari
- Firenze Ospedale Careggi — Careggi
- Azienda Ospedaliera di Catania — Catania
- Uni. di Modena — Modena
- Azienda Ospedaliera Universitaria Senese — Siena
- Maurizano Torino (turin) — Turin
- … and 1 more center
Germany · 8 centers
- Klinikum Augsburg — Augsburg
- Evangelisches Krankenhaus Hubertus — Berlin
- Klinikum Chemnitz — Chemnitz
- University Heart Center Freiburg — Freiburg im Breisgau
- Aortic Center University Hospital — Göttingen
- Bonifatius Hospital — Lingen
- St. Franziskus Hospital — Münster
- University Hospital Tübingen — Tübingen
Netherlands · 7 centers
- Vumc Amsterdam — Amsterdam
- Rijnstate Arnham — Arnhem
- Medisch Spectrum Twente — Enschede
- UMC Gronigen — Groningen
- St. Antonius Ziekenhuis — Nieuwegein
- Erasmus University Medical Center — Rotterdam
- Diakonessenhuis — Utrecht
Spain · 4 centers
- Hospital Universitari Germans — Badalona
- Hospital Clinic i Provincial de Barcelona — Barcelona
- Hospital Universitari Valle Hebrón de Barcelona — Barcelona
- Hospital Universitario Central de Asturias, Oviedo — Oviedo
United Kingdom · 4 centers
- Royal Derby Hospital — Derby
- Hull Royal Infirmary — Hull
- Manchester Royal Infirmary — Manchester
- Oxford University Hospital — Oxford
Portugal · 3 centers
- Centro Hospital Uni Lisboa Norte — Lisbon
- Hospital de Santa Marta — Lisbon
- CHU Sao Joao — Porto
Belgium · 2 centers
- Imeldaziekenhuis — Bonheiden
- Clinques Uni. St Lucs — Brussels
France · 2 centers
- Hôpital Pneumologique et Cardiovasculaire Louis-Pradel — Bron
- CHU St Etienne — Saint-Etienne
Switzerland · 2 centers
- Luzerner Kantonsspital — Lucerne
- Civico, Ospedale Regionale — Lugano
Identifiers
NCT: NCT04246463 · TiGER-001