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

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

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Phase N/A
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Overview

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

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

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.

Study details
    Abdominal Aortic Aneurysm

NCT06990048

Endologix

15 October 2025

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