The Long-Term EVAR Assessment and Follow-Up (LEAF) Study for the AFX2 System
LEAF
1 other identifier
observational
2,000
1 country
1
Brief Summary
This is an observational, retrospective, multicenter study to evaluate the performance of the AFX2 System using real world evidence from VQI-VISION.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 21, 2023
CompletedFirst Submitted
Initial submission to the registry
May 12, 2025
CompletedFirst Posted
Study publicly available on registry
May 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
May 25, 2025
May 1, 2025
3.6 years
May 12, 2025
May 19, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Long Term Safety
10 Years
Interventions
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
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Ruptured AAA repair with the AFX2 or comparator device
- Patients with AFX2 in AFX relining, or relined comparator grafts.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Dartmouth Institute
Lebanon, New Hampshire, 03756, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2025
First Posted
May 25, 2025
Study Start
September 21, 2023
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
May 25, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share