Status:
RECRUITING
Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
Lead Sponsor:
W.L.Gore & Associates
Conditions:
AAA - Abdominal Aortic Aneurysm
Eligibility:
All Genders
18+ years
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 Devi...
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 ...
Eligibility Criteria
Inclusion
- Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements
- Patient has been or is intended to be treated with an eligible registry device
- Patient is age ≥ 18 years at time of informed consent signature.
Exclusion
- Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.
- Patient with exclusion criteria required by local law.
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.
Key Trial Info
Start Date :
May 7 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2042
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT06218875
Start Date
May 7 2024
End Date
September 30 2042
Last Update
September 25 2025
Active Locations (43)
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1
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, United States, 72205
2
University of Southern California
Los Angeles, California, United States, 90033
3
Stanford University School of Medicine
Palo Alto, California, United States, 94304
4
Mount Sinai Vascular Institute
Miami Beach, Florida, United States, 33140