Registry for safety and performance of Terumo Aortic endovascular grafts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Long Beach Memorial Medical Center
  Long Beach, California, United States Recruiting
• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting
• UC Health Memorial Hospital Center
  Colorado Springs, Colorado, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting
• MedStar Washington Hospital Center
  Washington D.C., District of Columbia, United States Recruiting
• University of Florida
  Gainesville, Florida, United States Recruiting

+8 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Michelle Durnan
• Email: m.durnan@terumoaortic.com
• Phone: +44 141 343 0195

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.