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 Follow up


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General
Study Status Completed
Application Number /
Requirement Number		 P020004 S006/ PAS001
Date Original Protocol Accepted 06/02/2004
Date Current Protocol Accepted 06/02/2004
Study Name Long Term Follow up
Device Name EXCLUDER BIFURCATED ENDOPROTHESIS
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The study is a multi-site, non-randomized, combination prospective and retrospective observational cohort study to evaluate the performance of the Gore Excluder abdominal aortic anuerysm Endoprosthesis Low Permeability device in the primary treatment of infrarenal abdominal aortic aneurysms. This evaluation will assess the incidence of aneurysm volume increase and morphology over time in subjects treated with the device.
Study Population Patients were randomly selected from the 98-03 Pivotal Trial who were treated with the original GORE EXCLUDER device and had a CT scan performed at 24 months
Sample Size 140 subjects and 120 controls, 9 sites
Key Study Endpoints Device related adverse events, aneurysm diameter, aneurysm volume, death, and conversions.
Follow-up Visits and Length of Follow-up Endpoints are to be assessed at are to be assessed at baseline, post-procedure, at one month, six months, one year and two years post-procedure.
Interim or Final Data Summary
Interim Results Study completed, see final results.
Actual Number of Patients Enrolled 139 patients
Actual Number of Sites Enrolled 8 sites
Patient Follow-up Rate 89%
Final Safety Findings The final analysis showed very good device performance
Study Strengths & Weaknesses Weakness: 1) Combination of retrospective and prospective data made interpretation somewhat difficult; 2) Small number of sites; Strength: Subjects and controls were well matched.
Recommendations for Labeling Changes None


Long Term Follow up Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
PAS Annual Status Report 06/21/2007 06/21/2007 On Time
Yearly Report 06/02/2008 06/03/2008 Overdue/Received
Final Report 06/30/2009 05/13/2009 On Time


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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