Actively Recruiting
Long-Term Follow-Up Study of GORE4 EXCLUDER4 Endovascular Devices for Treating Abdominal Aortic Aneurysm
Led by W.L.Gore & Associates · Updated on 2026-02-05
2000
Participants Needed
90
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are collecting long-term real-world data on patients treated with the GORE4 EXCLUDER4 Conformable AAA Endoprosthesis EXCC Device or the Iliac Branch Endoprosthesis IBE Device for abdominal aortic aneurysm AAA. This observational registry aims to follow patients for up to 10 years after their endovascular procedure to assess outcomes related to these devices used in routine clinical practice. Participants include patients who have been or will be treated with either the EXCC or IBE device as part of their standard care. The choice of treatment and diagnostic imaging is determined by the treating physician. Patients will be grouped based on the device they receive those treated with the EXCC Device and those treated with the IBE Device. During the study, participants will return for regular follow-up visits as requested by their surgeon. They will report any issues related to the device or surgery to their doctor. Researchers will monitor various outcomes including technical success of device deployment, mortality related to the aneurysm, lesion rupture and enlargement, device migration, device integrity, renal function changes, and need for additional interventions over a 10-year period.
CONDITIONS
Brief Title
Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
Research Team
K
Karen Martin
A
A. Lekuti
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