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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
  • The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

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

Phone: (301) 796-6134
Fax: (301) 847-8140

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Application Number P060008
Current Protocol Accepted 01/21/2014
Study Name OSB Lead-Dual Antiplatelet Study
Study Status Completed
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of the Dual Antiplatlet Study is to evaluate

multiple durations of DAPT following DES   show the rest ...
Study Population Description This device is indicated for improving luminal diameter for

the treatment of de novo lesions <   show the rest ...
Sample Size Up to 4200 patients will be randomized for participation in

DAPT. The sample size is estimated   show the rest ...
Data Collection No endpoints are specified for the descriptive analyses of

the DAPT study.

Secondary Endpoints: Stent thrombosis, cardiac   show the rest ...
Followup Visits and Length of Followup 60 months post index procedure
Final Study Results
Actual Number of Patients Enrolled Overall: 4, 199 subjects

On-label: 1,592 subjects

Actual Number of Sites Enrolled 82 sites
Patient Followup Rate Overall: At three years: 85.8% (3579/4173) On-label: At three years: 86.3% (1370/1588)
Final Safety Findings The primary endpoint (12-month Cardiac Death or myocardial infarction) was met as the difference of   show the rest ...
Study Strengths and Weaknesses This study provides longer term (3 years) safety and effectiveness results of the TAXUS Liberté   show the rest ...
Recommendations for Labeling Changes Labeling changes are not recommended since this device is no longer on the market.

OSB Lead-Dual Antiplatelet Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
18 month report 06/29/2011 06/29/2011 On Time
24 month report 12/27/2011 12/27/2011 On Time
36 month report-3 year report 12/27/2012 12/26/2012 On Time
4 year report 12/26/2013 12/20/2013 On Time
5 year report 12/26/2014 12/23/2014 On Time
Final Report 10/02/2015 10/02/2015 On Time

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