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Registry for safety and performance of Terumo Aortic endovascular grafts

A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts

Observational Vascutek Ltd. · NCT04246463

This study is collecting information from patients with abdominal and thoracic aortic aneurysms to see how safe and effective Terumo Aortic stent-grafts are in real-life use.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorVascutek Ltd. Industry-sponsored
Locations58 sites (Long Beach, California and 57 other locations)
Trial IDNCT04246463 on ClinicalTrials.gov

What this trial studies

This observational registry collects real-world data on the safety and performance of Terumo Aortic endovascular stent-grafts used in patients with abdominal and thoracic aortic aneurysms. It aims to gather patient-reported outcomes and health economic data following the use of these devices in standard clinical practice. The registry is multi-center and open-label, allowing for a diverse patient population and comprehensive data collection. Patients will be followed up to assess long-term outcomes and adherence to the registry protocol.

Who should consider this trial

Good fit: Ideal candidates include patients aged according to local regulations who require aortic endovascular repair with an approved or custom Terumo Aortic graft.

Not a fit: Patients who are unable or unwilling to comply with the study follow-up regime or have contraindications per the device's instructions for use may not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could provide valuable insights into the effectiveness and safety of Terumo Aortic grafts, potentially improving patient outcomes in aortic repair procedures.

How similar studies have performed: Other observational registries have successfully provided important safety and performance data for similar endovascular devices, indicating a promising approach for this registry.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Long Beach, California and 57 other locations

+8 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Abdominal Aortic AneurysmThoracic Aortic AneurysmSurgery
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.