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

Endologix2,000 enrolled

Overview

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

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

2,000

Conditions

Abdominal Aortic Aneurysm

Interventions

AFX2 SystemDEVICE

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

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

The Dartmouth Institute

Lebanon, New Hampshire, United States

RECRUITING

Outcomes

Primary Outcomes

Rates of AAA Rupture, Reintervention and Mortality

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

Time frame: 5 Years

Incidence of Endoleak

Cummulative incidence of Type III endoleaks at 5 years.

Time frame: 5 Years

Secondary Outcomes

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.

Time frame: 10 Years

Central Contacts

Tammy Stiver

CONTACT

1-513-673-1452 tstiver@endologix.com

Data from ClinicalTrials.gov

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