Follow-up of people receiving Terumo Aortic stent grafts for aortic aneurysms
Collects safety and performance information on Terumo Aortic grafts in adults with aortic aneurysms.
Key facts
- Who runs it
- Vascutek Ltd.
- Where
- Lisbon and Porto, PortugalSee the 3 sitesAlso in 9 other countries, 55 sites
- Trial code
- Registry title
- Terumo Aortic Global Endovascular Registry
- Status
- Recruiting
- People taking part
- 1,000 people, planned
- Started
- 17 Dec 2019
- Expected to end
- Nov 2030
- Type of study
- Observational, 4 groups
- Treatments tested
- Thoracic
- Abdominal
- Custom Device
- Illiac Artery
- Record updated
- 13 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people who need repair of the main body artery (aorta) from inside the blood vessel with a Terumo Aortic stent graft. This includes approved, CE marked or custom-made grafts.
- Age
- 18 Years and older (minimum age as per local regulations)
- Sex
- All
- Disease stage
- Aneurysm (bulging) of the abdominal or chest aorta, or of the iliac artery in the pelvis, or other reasons for this repair. Emergency cases, such as injuries, can join if the ethics committee allows consent after the procedure.
Main reasons for not taking part
- Unable or unwilling to follow the study follow-up visits
- The device should not be used for the person according to its instructions for use (IFU)
- Medical, social or psychological problems that, in the investigator's view, stop the person from having the treatment and the tests before and after it
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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 take part
- 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
Where in Portugal
Also in 9 other countries, 55 sites
- Centro Hospital Uni Lisboa NorteLisbon, PortugalContact: Pedro Amorim, DR (principal investigator)Taking people
- Hospital de Santa MartaLisbon, PortugalContact: Emilla Ferrira, Dra (principal investigator)Taking people
- CHU Sao JoaoPorto, PortugalContact: Michelle DurnanNo longer taking part
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Thoracic - TEVAR
Treatment: Thoracic
- Abdominal - EVAR
Treatment: Abdominal
- Custom Device
- Other indications
Isolated Iliac Artery Aneurysm (IIAA)
Treatment: Illiac Artery
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts
- Plain-language title
- Follow-up of people receiving Terumo Aortic stent grafts for aortic aneurysmsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 13 March 2026