NCT04246463 Terumo Aortic Global Endovascular Registry
| NCT ID | NCT04246463 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vascutek Ltd. |
| Condition | Abdominal Aortic Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2019-12-17 |
| Primary Completion | 2029-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2019-12-17 with a primary completion date of 2029-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04246463 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Abdominal Aortic Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04246463 currently recruiting?
Yes, NCT04246463 is actively recruiting participants. Contact the research team at m.durnan@terumoaortic.com for enrollment information.
Where is the NCT04246463 trial being conducted?
This trial is being conducted at Long Beach, United States, Aurora, United States, Colorado Springs, United States, New Haven, United States and 11 additional locations.
Who is sponsoring the NCT04246463 clinical trial?
NCT04246463 is sponsored by Vascutek Ltd.. The trial plans to enroll 1,000 participants.