f Post-Approval Studies (PAS) Database
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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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Comprehensive/Linked-Registry Based Surv


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General
Study Status Other
Application Number /
Requirement Number		 P110032 / PAS002
Date Original Protocol Accepted 06/06/2014
Date Current Protocol Accepted  
Study Name Comprehensive/Linked-Registry Based Surv
Device Name AORFIX FLEXIBLE STENT GRAFT SYSTEM
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Objectives Surveillance of Aorfix patients entered into the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI)
Study Population Patients implanted with the Aorfix for its intended use
Sample Size 234 prospectively enrolled patients
Key Study Endpoints Procedural information, including the number of devices used, procedural duration, blood loss, and postoperative leg or bowel ischemia. The surveillance should also monitor aneurysm-related mortality, device migration, fracture in the fixation zone, conversion to open surgery, change in aneurysm size, aneurysm rupture, graft patency, secondary interventions, change in renal function, and endoleaks (including Type)
Follow-up Visits and Length of Follow-up 5 years
Interim or Final Data Summary
Interim Results Clinically assessed patency at 3 and 4 years was 100% (24/24 and 15/15, respectively) for the main body and limbs. No device migration
or fracture was observed. 7 patients demonstrated sac expansion by volume.
Actual Number of Patients Enrolled 42
Actual Number of Sites Enrolled 17
Patient Follow-up Rate 36/36 (100%) clinical follow-up and 11/35 (11%) CT follow-up at 3 years
24/33 (73%) clinical follow-up and 6/33 (18%) CT follow-up at 4 years
Study Strengths & Weaknesses The device is no longer marketed in the U.S. The study is on hold and there is no continued enrollment. Enrollment is low and CT follow-up is
limited, making it difficult to interpret results from minimal data. Patency is appropriate and no device migration or fracture was
observed.


Comprehensive/Linked-Registry Based Surv Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
FDA 6 month report 08/15/2014 08/07/2014 On Time
FDA 1 year report 02/14/2015 06/05/2015 Overdue/Received
FDA 18 month report 08/15/2015 08/17/2015 Overdue/Received
FDA 2 year report 02/14/2016 02/12/2016 On Time
FDA 30 month report 08/15/2016 10/13/2016 Overdue/Received
FDA 3 year report 02/15/2017 03/23/2017 Overdue/Received
FDA 4 year report 02/14/2018 11/09/2018 Overdue/Received
FDA 5 year report 02/14/2019 10/17/2019 Overdue
FDA 6 year report 02/14/2020 04/20/2020 Overdue/Received


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

Additional Resources

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