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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Long term


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General
Study Status Completed
Application Number /
Requirement Number		 P990020 / PAS001
Date Original Protocol Accepted 09/28/1999
Date Current Protocol Accepted 09/28/1999
Study Name Long term
Device Name ANEURX STENT GRAFT SYSTEM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives The study was a multi-center prospective clinical trial that involved 19 sites. The first five subjects enrolled at each site were enrolled in the surgical arm of the study. All following sequential enrollments received the AneuRx stent graft.
Study Population Patients were candidate for surgical repair of an infrarenal aortic or aorto-iliac aneurysm.
Sample Size 923 patients, 16 sties
Key Study Endpoints The primary endpoint was aneurysm related mortality at 5 years. Secondary endpoints included 1) Delivery success, 2) Deployment success, 3) Stent graft migration, measured by CT, angiography, ultrasound, or pathological analysis, 4) Aneurysm exclusion, evidence of blood flow around or through the stent graft into the aneurysm, 5) Stent graft patency, evidenced by CT, angiography, ultrasound or pathological analysis, 6) Device integrity, 7) Mechanical integrity, 8) Major morbidity (rupture, conversion, and major adverse events, and 9) Mortality.
Follow-up Visits and Length of Follow-up Follow-up was scheduled at 1 month, 6 months, and 1 year post-procedure, then every 6 months for the duration of the implant, up to 5 years.
Interim or Final Data Summary
Interim Results Study completed, see final results.
Actual Number of Patients Enrolled 931 patients
Actual Number of Sites Enrolled 16 sites
Patient Follow-up Rate 75%
Final Safety Findings Late aneurysm-related mortality accelerated in years 4 and 5 and was very high compared to open surgical controls.
Study Strengths & Weaknesses Strength: Prospective follow-up design; Weakness: A literature control group that lacked some important information was used as a comparison group for the primary endpoint.
Recommendations for Labeling Changes We recommended that labeling changes be made to reflect the high aneurysm-related mortality rate in later years. Review of the labeling change is currently being done.


Long term Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Annual Report 01/10/2006 01/10/2006 On Time
Final PAS report 04/30/2008 05/27/2008 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

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