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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Longterm PAS


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General
Study Status Terminated
Application Number /
Requirement Number		 P070016 / PAS001
Date Original Protocol Accepted 11/26/2008
Date Current Protocol Accepted 12/06/2011
Study Name Longterm PAS
Device Name ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM
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 Objectives 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 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.
Key Study Endpoints 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.


Longterm PAS Reporting Schedule

Reporting 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 05/16/2017 On Time
10 year report 05/21/2018 05/17/2018 On Time
11 year report 05/21/2019 05/16/2019 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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