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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P040002 S070/ PAS001 |
| Date Original Protocol Accepted |
05/08/2023
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| Date Current Protocol Accepted |
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| Study Name |
VQI and VISION EVAR Registry Analysis
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| Device Name |
AFX2 Endovascular AAA System
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| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
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| Data Source |
External Registry
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The AFX2 LEAF Study is an observational, retrospective and prospective, multicenter study to evaluate the performance of the AFX2 System using real world evidence from VQI-VISION. Further information on the study design is included in the VQI LEAF System Protocol.
The primary objective of this study is to valuate 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
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| Study Population |
The AFX2 System population includes patients who underwent EVAR as their first abdominal aortic aneurysm repair within the VQI EVAR registry
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| Sample Size |
Clinical Endpoint
Number of subjects: Minimum 2,000 AFX2 subjects and 18,000 comparator graft subjects
Imaging Endpoint
Number of subjects: Minimum 315 AFX2 subjects evaluable at 5 years
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| Key Study Endpoints |
Co Primary Endpoints
The primary clinical endpoint is the rate of the composite of AAA rupture, aortic-related reintervention, and mortality through 5 years.
- The primary imaging-driven endpoint is the cumulative incidence of Type III endoleaks at 5 years.
Secondary study endpoints:
Secondary endpoints through 10 years include:
• AAA rupture
• Aortic-related reintervention (including indication for and type of 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
• Limb occlusion
*If a patient has not had a reintervention after a Type III endoleak is detected on imaging, additional clinical information will be gathered from the site to determine the reason that the image-only detected Type III endoleak has not been treated or if treatment is now planned.
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| Follow-up Visits and Length of Follow-up |
Follow-up data of enrolled patients will be analyzed for the relevant cohorts through 5 years (primary endpoints) and 10 years (secondary endpoints). As this is an observational study using real world evidence, follow-up will be based on standard of care.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
24,020 in VQI-VISION EVAR Registry
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| Actual Number of Sites Enrolled |
N/A
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| Patient Follow-up Rate |
Follow-up data was provided through 3 years. There were 773 AFX2 subjects that reached 3 year follow-up.
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