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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: AFX2 System

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • The Dartmouth Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Approximately 20,000 patient data will be extracted from approximately 900 sites participating in the VQI EVAR registry in the US. A minimum of 2000 AFX2 System patients will be included.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of AAA Rupture, Reintervention and Mortality	Rate of the composite of AAA rupture, aortic-related reintervention, and morality through 5 years.	5 Years
Incidence of Endoleak	Cummulative incidence of Type III endoleaks at 5 years.	5 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long Term Safety	Rates of AAA rupture, aoritic-related reintervention, mortality, aneurysm related mortality, rate of imaging with CT, presence of untreated asymptomatic Type III endoleaks, occurrence of sac shrinkage, stability, and expansion >5mm in diameter, and limb occlusion at 10 years.	10 Years

Collaborators and Investigators

• Sponsor: Endologix
• Collaborators: Fivos

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: May 12, 2025
• First Submitted That Met QC Criteria: May 19, 2025
• First Posted (Actual): May 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: CP-0024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No