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.
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.
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