Gore Together Aortic Registry
Research type
Research Study
Full title
Assessment of Long Term, Endovascular AAA Intervention using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
IRAS ID
339420
Contact name
Said Abisi
Contact email
Sponsor organisation
W. L. Gore and Associates, inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
13 years, 8 months, 31 days
Research summary
This is a post-market Registry that will include subjects treated with the CE marked GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device) or the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device) as part of routine clinical practice. The Registry will collect real-world data (RMD) and outcomes over a 10-year post procedure follow-up period.
Registry participants will be derived from patients presenting with vascular disease that may benefit from the placement of an endovascular stent graft. Only patients who meet all the inclusion and none of the exclusion criteria will be included in the registry.
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 surgeon. Patients will report any issues they may have regarding the device or surgery to their surgeon/doctor.
A total of 3500 subjects will be implanted in this Registry worldwide. It is anticipated that each Registry site, on average, will enrol approximately 7-9 EXCC and 3-5 IBE Device subjects over the course of a year.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
24/SC/0152
Date of REC Opinion
30 May 2024
REC opinion
Further Information Favourable Opinion