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Recruiting NCT06990048

The Long-Term EVAR Assessment and Follow-Up (LEAF) Study for the AFX2 System

Trial Parameters

Condition Abdominal Aortic Aneurysm
Sponsor Endologix
Study Type OBSERVATIONAL
Phase N/A
Enrollment 2,000
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2023-09-21
Completion 2027-05
Interventions
AFX2 System

Brief Summary

This is an observational, retrospective, multicenter study to evaluate the performance of the AFX2 System using real world evidence from VQI-VISION.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * Ruptured AAA repair with the AFX2 or comparator device * Patients with AFX2 in AFX relining, or relined comparator grafts.

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