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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 P060001
Most Recent Protocol Version Approved 08/02/2007
Study Name CREATE PAS
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 is a prospective, multi-site, non-randomized study in which consecutive qualifying subjects undergoing carotid interventional   show the rest ...
Study Population Description The PROTÉGÉ Stent will be implanted in stenoses in the common and/or internal carotid artery   show the rest ...
Sample Size A total of xx subjects in two cohorts will be enrolled into the study. The   show the rest ...
Data Collection One-year Cohort: Subjects will be evaluated for the combined incidence of Major Adverse Cardiac and   show the rest ...
Followup Visits and Length of Followup Folllow-up for the One-year Cohort includes a pre-discharge visit, 30-day and one year clinic visits   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 1,500
Actual Number of Sites Enrolled 57
Patient Followup Rate 93% (1,400/1,500)
Final Safety Findings In the total cohort, the death rate was ... The one-year serious adverse event rate   show the rest ...
Final Effectiveness Findings The primary analysis of the one-year cohort is an assessment of Major Adverse Cardiac and   show the rest ...
Study Strengths and Weaknesses The sponsor attained over ... follow-up for the entire study. The study was not powered   show the rest ...
Recommendations for Labeling Changes yes


CREATE PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 07/25/2007 07/23/2007 On Time
1 year report 01/24/2008 01/18/2008 On Time
18 month report 07/24/2008 07/31/2008 Overdue/Received
2 year report 01/23/2009 01/27/2009 Overdue/Received
3 year report 01/23/2010 01/21/2010 On Time
48 month report 01/21/2011 01/21/2011 On Time
4 year Report 01/23/2012 01/23/2012 On Time
Final Report 04/25/2012 04/25/2012 On Time
unsolicited report 01/22/2013 01/22/2013 On Time

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