The Long-Term EVAR Assessment and Follow-Up (LEAF) Study for the AFX2 System
Endologix
Summary
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
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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.
Interventions
- DeviceAFX2 System
The AFX2 System comprises of the following: AFX2 Bifurcated Endograft System and delivery system AFX Vela Proxmal Endograft System and delivery system AFX Stand Alone Endograft System and delivery system
Location
- The Dartmouth InstituteLebanon, New Hampshire