Abdominal Aortic AneurysmTiGERNCT04246463
Terumo Aortic Global Endovascular Registry
An observational study of Abdominal Aortic Aneurysm and Thoracic Aortic Aneurysm, run by Vascutek Ltd. at 58 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm, Surgery
- What is being tested?
- Thoracic, Abdominal and Custom Device
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 58 sitesin 10 countries
- Study dates
- 17 Dec 2019to Nov 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
58 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
58 sites in 10 countries
United States17 sites, 17 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Shinichi Fukuhara, MD
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Rafael Malgor, MD
- Recruiting
Ascension Texas Cardiovascular / UT Dell Medical School
Austin, Texas, 78705
Joshua Grimm
- Recruiting
Cooper University Hospital
Camden, New Jersey, 08103
Joseph Lombardi
- Recruiting
University of Virgina
Charlottesville, Virginia, 22908
Bezhad Farivar
- Recruiting
Loyola University of Chicago (Loyola)
Chicago, Illinois, 60153
Carlos Bechara, MD
- Recruiting
UC Health Memorial Hospital Center
Colorado Springs, Colorado, 80909
Melham Sharafuddin
- Recruiting
University of Florida
Gainesville, Florida, 32610
Eric Jeng
- Recruiting
Ascension St. Vincent Heart Center
Indianapolis, Indiana, 46260
Sina L Moainie, MD
- Recruiting
Long Beach Memorial Medical Center
Long Beach, California, 90806
Ali Khoynezhad
- Recruiting
Yale University
New Haven, Connecticut, 06520
Prashanth Vallabhajoysyula
- Recruiting
Sentara Heart Hospital
Norfolk, Virginia, 22042
Jean Panneton, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Wilson Szeto
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232
Ibrahim Sulton
- Recruiting
University of Utah
Salt Lake City, Utah, 84132
Jason Glozbach
- Recruiting
Baylor, Scott & White Health (BSW Health)
Texas City, Texas, 75093
Dennis Gable, MD
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Christian Shults
Italy9 sites, 9 recruiting
- Recruiting
Policlinico Consorziale di Bari
Bari
Sammy Jassal
Raffaele Pulli, Prof
- Recruiting
Compensorio Sanitario Bolzano
Bolzano
Reinhold Perkman, Dr
- Recruiting
Cagliari-Ospedale Brotzu
Cagliari
Sammy Jassal
Stefano Camparini, Dr
- Recruiting
Firenze Ospedale Careggi
Careggi
Carlos Pratesi, DR
- Recruiting
Azienda Ospedaliera di Catania
Catania
Pierfranceso Veroux, Dr
- Not yet recruiting
Uni. di Modena
Modena
Roberto Silingardi, Prof
- Recruiting
Azienda Ospedaliera Universitaria Senese
Siena
Eugenio Neri, Prof
- Recruiting
Maurizano Torino (turin)
Turin
A Gaggiano, Dr
- Not yet recruiting
Turin Uni. Hospital
Turin
Fabio Verzini
Germany8 sites, 7 recruiting
- Recruiting
Klinikum Augsburg
Augsburg
Alexander Hyhlik-Duerr, Prof Dr Med
- Recruiting
Evangelisches Krankenhaus Hubertus
Berlin
Ernst Weigang, Prof.Dr.Med.
- Recruiting
Klinikum Chemnitz
Chemnitz
Sven Seifert
- Recruiting
University Heart Center Freiburg
Freiburg im Breisgau
Roman Gottardi, Dr
- Withdrawn
Aortic Center University Hospital
Göttingen
- Recruiting
Bonifatius Hospital
Lingen
Dr J Tesarek
- Recruiting
St. Franziskus Hospital
Münster
Martin Austermann
- Recruiting
University Hospital Tübingen
Tübingen
Mario Lescan, Dr
Netherlands7 sites, 7 recruiting
- Recruiting
Vumc Amsterdam
Amsterdam
A.w.J Hoksbergen
- Recruiting
Rijnstate Arnham
Arnhem
M.M.P.J Reihnen
- Recruiting
Medisch Spectrum Twente
Enschede
R.H Geelkerken
- Recruiting
UMC Gronigen
Groningen
Clark Zeebregts
- Not yet recruiting
St. Antonius Ziekenhuis
Nieuwegein, 3430
Study Coordinator
Hans Dr Smeenk
- Recruiting
Erasmus University Medical Center
Rotterdam
Hence Verhagen, Prof
- Recruiting
Diakonessenhuis
Utrecht
Mattijs De Vries, Prof
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitari Germans
Badalona
Secundi Lagostera, DR
- Recruiting
Hospital Clinic i Provincial de Barcelona
Barcelona
V Riambau
Vincent Riambau, Prof
- Recruiting
Hospital Universitari Valle Hebrón de Barcelona
Barcelona
Sergi Montoya Bellmunt, DR
- Recruiting
Hospital Universitario Central de Asturias, Oviedo
Oviedo
Manuel Alonso, Dr
United Kingdom4 sites, 4 recruiting
- Not yet recruiting
Royal Derby Hospital
Derby
Ganesh Dr Kuhan
- Recruiting
Hull Royal Infirmary
Hull
Raghuram Lakshminarayan, DR
- Recruiting
Manchester Royal Infirmary
Manchester
David Murray, MR
- Recruiting
Oxford University Hospital
Oxford
Raman Uberoi, DR
Portugal3 sites, 2 recruiting
- Recruiting
Centro Hospital Uni Lisboa Norte
Lisbon
Pedro Amorim, DR
- Recruiting
Hospital de Santa Marta
Lisbon
Emilla Ferrira, Dra
- Withdrawn
CHU Sao Joao
Porto
Belgium2 sites, 1 recruiting
- Recruiting
Imeldaziekenhuis
Bonheiden
Wouter van den Eynde
- Withdrawn
Clinques Uni. St Lucs
Brussels
France2 sites, 2 recruiting
- Recruiting
Hôpital Pneumologique et Cardiovasculaire Louis-Pradel
Bron
Antoine Millon, Prof
- Recruiting
CHU St Etienne
Saint-Etienne
Ben Ahmed, Dr
Switzerland2 sites, 1 recruiting
- Recruiting
Luzerner Kantonsspital
Lucerne
Maani Hakimi
- Withdrawn
Civico, Ospedale Regionale
Lugano
About this study
Official title: A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts
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.
Read the 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.
- Conditions
- Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm, Surgery
- Being tested
- Thoracic, Abdominal, Custom Device, Illiac Artery
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThoracicDevice
Implant of a Relay stent graft system
AbdominalDevice
Implant with an Anaconda or Treo Stent graft system
Custom DeviceDevice
Implant of a Fenestrated device such as Fenestrated Anaconda or Fenestrated TREO, Relay Branch or other customised device
Illiac ArteryDevice
Implant with an Anaconda Iliac leg only
| Study group | Role | What they receive |
|---|---|---|
| Thoracic - TEVAR | Not described Receives: Device: Thoracic | |
| Abdominal - EVAR | Not described Receives: Device: Abdominal | |
| Custom Device | Not described Receives: Device: Custom Device | |
| Other indications | Isolated Iliac Artery Aneurysm (IIAA) Receives: Device: Illiac Artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days post implant
Secondary outcomes (3)
Technical Success
defined as:
Successful delivery of the device through the vasculature (i.e. ability to deliver the implant to the intended location without the need for unanticipated corrective intervention related to delivery).
Deployment of the endovascular stent-graft in the planned location with coverage of the target lesion (or entry tear in the case of dissection);Absence of unplanned coverage or aortic branch vessels; Patency of the endovascular stent-graft, absence of device deformations (e.g. kinks, stent eversion, maldeployment, misaligned deployment) requiring unplanned placement of an additional device within the endovascular stentgraft, and;Successful withdrawal (i.e. successful withdrawal of the delivery system, without the need for unanticipated corrective intervention related to withdrawal). Absence of Type Ia, Type Ib, Type IIIa and IIIb endoleak that extends beyond 30 days by confirmatory imaging (CTA, magnetic resonance angiography [MRA], or duplex ultrasound).
Measured: Day 0
Composite Clinical Success
defined as the absence of: Target lesion related mortality Type Ia, Ib, IIIa and IIIb endoleak Graft infection Stent patency <50% Target lesion aortic rupture Conversion to open repair Arrest of the original pathological process (e.g., total aortic diameter expansion >5 mm in the aorta that has a study endograft, embolization from penetrating ulcer, extension of dissection, false lumen perfusion) or a new aortic pathology as a result of the intervention (e.g., pseudoaneurysm, dissection, intramural hematoma, unintentional adverse dissection septum rupture, stent-graft induced aortic wall injury, new aortobronchial/tracheal or aortoenteric fistula formation)
Measured: 1 year
Additional Endpoints
All-cause mortality Safety (MAEs, all related adverse events) Target lesion reintervention, all secondary interventions Device performance based on imaging assessments of all morphological variables (aortic remodeling, all endoleaks, any loss of patency, stent-graft migration, device integrity, etc.)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start17 Dec 2019
- Primary completionNov 2029 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vascutek Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bolton Medical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246463
- Sponsor's protocol ID
- TiGER-001
- Acronym
- TiGER
- Status last verified
- Jul 2025
- First submitted
- 26 Nov 2019
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts
- ClinicalTrials.gov ID
- NCT04246463
- Acronym / sponsor ID
- TiGER / TiGER-001
- Conditions
- Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm, Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Vascutek Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Bolton Medical
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Thoracic - TEVAR | – | Device: Thoracic |
| Abdominal - EVAR | – | Device: Abdominal |
| Custom Device | – | Device: Custom Device |
| Other indications | – | Device: Illiac ArteryIsolated Iliac Artery Aneurysm (IIAA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThoracicImplant of a Relay stent graft system | Device | Thoracic - TEVAR |
| AbdominalImplant with an Anaconda or Treo Stent graft system | Device | Abdominal - EVAR |
| Custom DeviceImplant of a Fenestrated device such as Fenestrated Anaconda or Fenestrated TREO, Relay Branch or other customised device | Device | Custom Device |
| Illiac ArteryImplant with an Anaconda Iliac leg only | Device | Other indications |
Primary outcome
Aortic Related Mortality
Time frame: 30 days post implant
Defined as any death occurring within 30 days of implant, due to rupture or following any procedure intended to treat the target lesion
3 secondary outcomes
Technical Success
Time frame: Day 0
Composite Clinical Success
Time frame: 1 year
Additional Endpoints
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
58 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm and Thoracic Aortic Aneurysm, run by Vascutek Ltd. at 58 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Italy, Germany, Netherlands, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Durnan (+44 141 343 0195, m.durnan@terumoaortic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic Related Mortality (time frame: 30 days post implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.