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

Launched by ENDOLOGIX · May 19, 2025

Keywords

ClinConnect Summary

The LEAF Study is looking at how well the AFX2 System performs in treating abdominal aortic aneurysms (AAAs), which are bulges in the main blood vessel that can be dangerous if they grow too large. This study is using real-world data from patients who have had this device implanted to see how it works over time. It is currently recruiting participants, and the good news is that anyone who has had the AFX2 System or one of the other three commonly used devices for their first AAA repair may be eligible to join.

If you participate in this study, you'll be part of a group that helps researchers understand the long-term outcomes of the AFX2 System. However, those who had emergency repairs for a ruptured aneurysm or specific types of device re-linings won't qualify for this study. This research is important because it can provide valuable insights into the effectiveness and safety of the AFX2 System, ultimately helping doctors make better choices for patients in the future.

Gender

ALL

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.