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OpenTrials
Active, Not Recruiting

NCT Number: NCT06990048

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

The Dartmouth Institute

Lebanon, New Hampshire, 03756, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AFX2 System

Device

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

Primary outcomes

  1. Rates of AAA Rupture, Reintervention and Mortality

    Time frame: 5 Years

    Rate of the composite of AAA rupture, aortic-related reintervention, and morality through 5 years.

  2. Incidence of Endoleak

    Time frame: 5 Years

    Cummulative incidence of Type III endoleaks at 5 years.

Secondary outcomes

  1. Long Term Safety

    Time frame: 10 Years

    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.

Sponsors and collaborators

Lead sponsor

Endologix

Industry

Collaborators

  • Fivos

Registry information

Acronym: LEAF

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 25, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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