An observational study in Abdominal Aortic Aneurysm, sponsored by Endologix. Active, not recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Endologix · Observational
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.
467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 165 across 217 observational studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →Endologix is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 9 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for May 2027, 44 months after the start.
Of 91 observational studies under Aortic Aneurysm, Abdominal, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 83. This study's planned 44 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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