Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06218875
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-01-11
Brief Title:
Endovascular AAA Intervention Using the GORE EXCLUDER Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
Sponsor:
WLGore Associates
Organization:
WLGore Associates
Study Overview
Official Title:
Assessment of Long Term Endovascular AAA Intervention Using the GORE EXCLUDER Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective observational post-market registry collecting outcomes through a 10-year post procedure follow-up for patients treated with the GORE EXCLUDER Conformable AAA Endoprosthesis EXCC Device or the GORE EXCLUDER Iliac Branch Endoprosthesis IBE Device as a part of routine clinical practice
Detailed Description:
The purpose of the Gore Together Aortic Registry is to collect real-world data RWD for Gore aortic endovascular devices Due to the nature of the program 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 surgeondoctor
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 surgeondoctor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None