Terumo Aortic Global Endovascular Registry

  • STATUS
    Recruiting
  • End date
    Nov 28, 2030
  • participants needed
    1000
  • sponsor
    Vascutek Ltd.
Updated on 19 February 2024

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.

Description

Post Market registry collecting real world, post-approval safety, performance, patient reported outcomes and health economic data on patients treated with Terumo Aortic endovascular stent-grafts in standard clinical practice.

Details
Condition Surgery, Abdominal aortic aneurysm, Thoracic aortic aneurysm, Surgical aspects, Surgery
Age 18years - 100years
Treatment Thoracic, Abdominal, Custom Device, Illiac Artery
Clinical Study IdentifierNCT04246463
SponsorVascutek Ltd.
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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)
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
Patient is eligible to be enrolled in or is currently actively participating in the Terumo Aortic Global FACT clinical study (FACT-001)
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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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