Terumo Aortic Global Endovascular Registry
TiGER
A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts
1 other identifier
observational
1,000
10 countries
58
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2019
Longer than P75 for all trials
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2019
CompletedStudy Start
First participant enrolled
December 17, 2019
CompletedFirst Posted
Study publicly available on registry
January 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2030
March 13, 2026
July 1, 2025
9.9 years
November 26, 2019
March 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Aortic Related Mortality
Defined as any death occurring within 30 days of implant, due to rupture or following any procedure intended to treat the target lesion
30 days post implant
Secondary Outcomes (3)
Technical Success
Day 0
Composite Clinical Success
1 year
Additional Endpoints
1 year
Other Outcomes (5)
Patient Outcome measure
1 Year
Health Economics
From Procedure to 1 Year
Health Economics
Day 0
- +2 more other outcomes
Study Arms (4)
Thoracic - TEVAR
Abdominal - EVAR
Custom Device
Other indications
Isolated Iliac Artery Aneurysm (IIAA)
Interventions
Implant of a Fenestrated device such as Fenestrated Anaconda or Fenestrated TREO, Relay Branch or other customised device
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vascutek Ltd.lead
- Bolton Medicalcollaborator
Study Sites (58)
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
UC Health Memorial Hospital Center
Colorado Springs, Colorado, 80909, United States
Yale University
New Haven, Connecticut, 06520, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Florida
Gainesville, Florida, 32610, United States
Loyola University of Chicago (Loyola)
Chicago, Illinois, 60153, United States
Ascension St. Vincent Heart Center
Indianapolis, Indiana, 46260, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232, United States
Ascension Texas Cardiovascular / UT Dell Medical School
Austin, Texas, 78705, United States
Baylor, Scott & White Health (BSW Health)
Texas City, Texas, 75093, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Virgina
Charlottesville, Virginia, 22908, United States
Sentara Heart Hospital
Norfolk, Virginia, 22042, United States
Imeldaziekenhuis
Bonheiden, Belgium
Clinques Uni. St Lucs
Brussels, Belgium
Hôpital Pneumologique et Cardiovasculaire Louis-Pradel
Bron, France
CHU St Etienne
Saint-Etienne, France
Klinikum Augsburg
Augsburg, Germany
Evangelisches Krankenhaus Hubertus
Berlin, Germany
Klinikum Chemnitz
Chemnitz, Germany
University Heart Center Freiburg
Freiburg im Breisgau, Germany
Aortic Center University Hospital
Göttingen, Germany
Bonifatius Hospital
Lingen, Germany
St. Franziskus Hospital
Münster, Germany
University Hospital Tübingen
Tübingen, Germany
Policlinico Consorziale di Bari
Bari, Italy
Compensorio Sanitario Bolzano
Bolzano, Italy
Cagliari-Ospedale Brotzu
Cagliari, Italy
Firenze Ospedale Careggi
Careggi, Italy
Azienda Ospedaliera di Catania
Catania, Italy
Uni. di Modena
Modena, Italy
Azienda Ospedaliera Universitaria Senese
Siena, Italy
Maurizano Torino (turin)
Turin, Italy
Turin Uni. Hospital
Turin, Italy
Vumc Amsterdam
Amsterdam, Netherlands
Rijnstate Arnham
Arnhem, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
UMC Gronigen
Groningen, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, 3430, Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands
Diakonessenhuis
Utrecht, Netherlands
Centro Hospital Uni Lisboa Norte
Lisbon, Portugal
Hospital de Santa Marta
Lisbon, Portugal
CHU Sao Joao
Porto, Portugal
Hospital Universitari Germans
Badalona, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
Hospital Universitari Valle Hebrón de Barcelona
Barcelona, Spain
Hospital Universitario Central de Asturias, Oviedo
Oviedo, Spain
Luzerner Kantonsspital
Lucerne, Switzerland
Civico, Ospedale Regionale
Lugano, Switzerland
Royal Derby Hospital
Derby, United Kingdom
Hull Royal Infirmary
Hull, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Oxford University Hospital
Oxford, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2019
First Posted
January 29, 2020
Study Start
December 17, 2019
Primary Completion (Estimated)
November 1, 2029
Study Completion (Estimated)
November 1, 2030
Last Updated
March 13, 2026
Record last verified: 2025-07