Abdominal Aortic Aneurysm
Conditions
Brief summary
This is an observational, retrospective, multicenter study to evaluate the performance of the AFX2 System using real world evidence from VQI-VISION.
Detailed description
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.
Interventions
DEVICEAFX2 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
Sponsors
Endologix
Fivos
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long Term Safety | 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. |
Countries
United States
Outcome results
None listed