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Clinical Trials in the USA / NCT06990048
Active, not recruiting Observational

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

NCT06990048 · tracked via the Priya Life Science USA tracker
Sponsor
Endologix
Phase
Observational
Started
2023-09-21
Last updated
2026-05-12

Condition(s) studied

Abdominal Aortic Aneurysm

Investigational drug(s) / intervention(s)

AFX2 System

AFX2 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

Study summary

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

Eligibility

Sex
ALL
Min age
—
Max age
—
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.

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
The Dartmouth Institute Lebanon New Hampshire

More Endologix trials in the USA

JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization Recruiting
The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry) Enrolling by invitation
Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication Active, not recruiting

Other trials for the same condition

Nectero EAST System Clinical Study Recruiting
Terumo Aortic Global Endovascular Registry Recruiting
Post-Approval Study of the TREO Abdominal Stent-Graft System Active, not recruiting
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study Active, not recruiting
Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06990048 on ClinicalTrials.gov ↗ ← All trials in the USA