Terumo Aortic Global Endovascular Registry

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Abdominal aortic aneurysm
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Brief Title

Terumo Aortic Global Endovascular Registry

Official Title

A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts

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.

Detailed 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.

Study Type

Observational

Primary Outcome

Aortic Related Mortality

Secondary Outcome

 Technical Success

Condition

Abdominal Aortic Aneurysm

Intervention

Thoracic

Study Arms / Comparison Groups

 Thoracic - TEVAR
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

1000

Start Date

December 17, 2019

Completion Date

November 2030

Primary Completion Date

November 2029

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)

               -  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)

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, +441418125555, [email protected]

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations

NCT ID

NCT04246463

Organization ID

TiGER-001

Responsible Party

Sponsor

Study Sponsor

Vascutek Ltd.

Collaborators

 Bolton Medical

Study Sponsor

, ,

Verification Date

January 2020