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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Longterm PAS


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General
Application Number P070016 / PAS001
Current Plan Approved 11/26/2008
Study Name OSB Lead-Longterm PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is an observational cohort of registry patients, chosen from a minimum of 15 multi-national investigative sites, with a maximum number of 25 patients enrolled at any one site.
Study Population Description Consecutive patients who meet the inclusion criteria and who are willing to participate will be enrolled in the study. For inclusion in the study, patients must have a descending thoracic aortic aneurysm of at least 5 cm diameter, or with a history of growth of at least 0.5 cm per year, or degenerative or atherosclerotic ulcer of at least 10 mm in depth and 20 mm in diameter, AND patient must not meet any of the general, medical or anatomical exclusion criteria.
Sample Size 300 subjects, up to 50 sites Factoring in a 10% dropout rate, that adds up to 300. This will include 160 endovascular treatment patients from the pivotal clinical trial, plus an additional 125 endovascular patients, which allows for 12 patients lost to follow-up.
Data Collection Aneurysm-related mortality is the primary endpoint. Additional endpoints to be assessed include device performance (change in aneurysm size, endoleaks, migration, device integrity, and secondary interventions) and morbidity.
Follow-up Visits and Length of Follow-up Patients will be followed for a total of five years. Termination of follow-up will occur 30 days following explant, and upon patient withdrawal, death or closure of pre-market study.
Final Study Results
Interim Safety Information Serious adverse events appear to be occurring at a rate that is no greater than expected, but there has not been much follow-up yet. However, it is difficult to assess how the rates of occurrence has varied over time because of the lack of accompanying denominator data.


OSB Lead-Longterm PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 11/21/2008 11/20/2008 On Time
1 year report 05/21/2009 05/20/2009 On Time
18 month report 11/21/2009 11/20/2009 On Time
2 year report 05/21/2010 05/14/2010 On Time
3 year report 05/21/2011 05/19/2011 On Time
4 year report 05/21/2012 05/21/2012 On Time
5 year report 05/21/2013 05/20/2013 On Time
6 year report 05/21/2014 05/21/2014 On Time
7 year report 05/21/2015 05/19/2015 On Time
8 year report 05/21/2016 05/20/2016 On Time
9 year report 05/21/2017    
10 year report 05/21/2018    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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