Status:
RECRUITING
The Long-Term EVAR Assessment and Follow-Up (LEAF) Study for the AFX2 System
Lead Sponsor:
Endologix
Collaborating Sponsors:
Fivos
Conditions:
Abdominal Aortic Aneurysm
Eligibility:
All Genders
Brief Summary
This is an observational, retrospective, multicenter study to evaluate the performance of the AFX2 System using real world evidence from VQI-VISION.
Detailed Description
Evaluate the clinical performance of the AFX2 System patients against other commercially available EVAR devices and evaluate the Type III endoleak occurrence in AFX2 System patients through 5 years.
Eligibility Criteria
Inclusion
- All patients implanted with the AFX2 System or the 3 most commonly used comparator devices who underwent EVAR as their first abdominal aortic aneurysm repair in the VQI EVAR registry will be included in this study.
Exclusion
- Ruptured AAA repair with the AFX2 or comparator device
- Patients with AFX2 in AFX relining, or relined comparator grafts.
Key Trial Info
Start Date :
September 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT06990048
Start Date
September 21 2023
End Date
May 1 2027
Last Update
May 25 2025
Active Locations (1)
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1
The Dartmouth Institute
Lebanon, New Hampshire, United States, 03756