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

Endologix

Status: Enrolling

Conditions: Abdominal Aortic Aneurysm

Treatments: Device: AFX2 System

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06990048

CP-0024

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.