TGR 23-02TB Registry
Research type
Research Study
Full title
Characterization of Mid-term Post Market Clinical Follow Up of GORE® TAG® Thoracic Branch Endoprosthesis Facilitated Aortic Arch and Descending Aorta Intervention
IRAS ID
346975
Contact name
Said Abisi
Contact email
Sponsor organisation
W.L.Gore and Associates
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 6 months, 30 days
Research summary
This is a post-market registry of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE) device as part of routine clinical practice. The registry will collect real world data up to two years following the initial TBE implant procedure.
Registry participants will come from patients who are presenting with vascular disease who may benefit from the implant of an endovascular stent graft and only participants who meet the inclusion/exclusion criteria will be included.
Patient selection, diagnostic imaging, and treatment interventions will be determined by physicians based on standard clinical practice. Therefore, the Sponsor will not be outlining requirements that would influence healthcare decisions.
Participants will be asked to return for regular scheduled visits as requested by their healthcare team. Patients will report any issues they may have regarding the device or surgery to their surgeon/doctor.
A total of 200 patients will be enrolled into the registry worldwide, with an approximate enrolment rate per site of 2-5 patients per year.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
25/NW/0121
Date of REC Opinion
25 Jun 2025
REC opinion
Further Information Favourable Opinion