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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.

Links

Contact Information

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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General
Application Number P070015
Current Protocol Accepted 07/02/2008
Study Name XIENCE Registry
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 Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study will 1) evaluate clinical outcomes in a cohort of real-world patients receiving the   show the rest ...
Study Population Description The XIENCE V Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter   show the rest ...
Sample Size 5000 patients, number of sites not listed
Data Collection The primary endpoints of the study are is stent thrombosis rates annually through 5 years   show the rest ...
Followup Visits and Length of Followup Clinical follow-up for this cohort will occur at 2, 3, 4, and 5 years.
Final Study Results
Actual Number of Patients Enrolled 5,020
Actual Number of Sites Enrolled 161
Patient Followup Rate 93%
Final Safety Findings The annual rate of ARC-defined definite and probable ST at 4 years for the first   show the rest ...
Final Effectiveness Findings The cumulative rates of cardiac death and MI through 4 years were 14.9% (676/4530, 95%   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 recommended to add a summary of the post-approval study results including   show the rest ...


XIENCE Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 12/31/2008 12/24/2008 On Time
1 year report 07/02/2009 06/30/2009 Overdue/Received
18 month report 12/31/2009 12/22/2009 On Time
2 year report 07/02/2010 06/29/2010 On Time
3 year report 07/02/2011 07/01/2011 On Time
primary analysis report 01/17/2012 01/17/2012 On Time
4 year report 07/01/2012 07/02/2012 Overdue/Received
5 year report 07/01/2013 02/28/2013 On Time
6 year report-FINAL REPORT 07/01/2014 08/12/2013 On Time

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