Terumo Aortic Global Endovascular Registry
A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts
Vascutek Ltd.
1,000 participants
Dec 17, 2019
OBSERVATIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria1
- 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.
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Interventions
Implant of a Relay stent graft system
Implant with an Anaconda or Treo Stent graft system
Implant of a Fenestrated device such as Fenestrated Anaconda or Fenestrated TREO, Relay Branch or other customised device
Implant with an Anaconda Iliac leg only
Locations(58)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04246463