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
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT04246463
Organization ID
TiGER-001
Responsible Party
Sponsor
Study Sponsor
Vascutek Ltd.
Collaborators
Bolton Medical
Study Sponsor
, ,
Verification Date
January 2021