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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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VQI and VISION EVAR Registry Analysis

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Study Status Ongoing
Application Number /
Requirement Number
P040002 S070/ PAS001
Date Original Protocol Accepted 05/08/2023
Date Current Protocol Accepted  
Study Name VQI and VISION EVAR Registry Analysis
Device Name AFX2 Endovascular AAA System
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
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
Study Population The AFX2 System population includes patients who underwent EVAR as their first abdominal aortic aneurysm repair within the VQI EVAR registry
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
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.
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.
Interim or Final Data Summary
Actual Number of Patients Enrolled 24,020 in VQI-VISION EVAR Registry
Actual Number of Sites Enrolled N/A
Patient Follow-up Rate Follow-up data was provided through 3 years. There were 773 AFX2 subjects that reached 3 year follow-up.

VQI and VISION EVAR Registry Analysis Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 11/06/2023 11/13/2023 Overdue/Received
1 year report 05/06/2024    
2 year report 05/05/2025    
3 year report 05/06/2026    
4 year report 05/05/2027    

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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