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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 P060033
Current Protocol Accepted 09/16/2008
Study Name Registry PROTECT CA
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This post-approval study (PAS) uses the pooled data from the PROTECT and PROTECT Continued Access   show the rest ...
Study Population Description The PROTECT and PROTECT CA patient populations include consecutive patients eligible for drug-eluting stent implantation   show the rest ...
Sample Size A minimum of 1,000 Endeavor patients will be enrolled in the US, including:

a. US patients enrolled   show the rest ...
Data Collection Primary Endpoint

ST rate defined as definite and probable stent thrombosis, according to the ARC   show the rest ...
Followup Visits and Length of Followup Length of follow-up: 5 years

Follow up at: 1, 6 , 12, 18, 24, 30, 36,   show the rest ...
Final Study Results
Actual Number of Patients Enrolled The PAS analyses included 1,769 on-label patients.
Actual Number of Sites Enrolled 64 sites
Patient Followup Rate At five years the follow-up rate was 94.6% (1673/1769).
Final Safety Findings The annual rate of ARC-defined definite and probable stent thrombosis at 5 years for on-label   show the rest ...
Final Effectiveness Findings The 5-year cumulative rate of cardiac death or myocardial infarction for on-label patients in PROTECT   show the rest ...
Study Strengths and Weaknesses The study had a low rate of attrition, thus minimizing selection bias. The study met   show the rest ...
Recommendations for Labeling Changes A labeling change is not needed because Medtronic Vascular has ceased manufacturing and distribution of   show the rest ...

Registry PROTECT CA Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
1 year report 01/31/2009 01/30/2009 On Time
18 month report 08/01/2009 07/30/2009 On Time
2 year report 01/31/2010 01/28/2010 On Time
3 year report 01/31/2011 01/28/2011 On Time
4 year report 01/31/2012 01/31/2012 On Time
5 year report 01/30/2013 01/30/2013 On Time
6 year report 01/30/2014 01/30/2014 On Time
7 year report-final report 03/31/2015 03/31/2015 On Time

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