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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 P040038
Current Protocol Accepted 02/05/2007
Study Name PROTECT Study
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
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 The PROTECT study is a prospective, multi-center, randomized, two-arm, open-label study.

The primary objective is to   show the rest ...
Study Population Description This device is indicated for the improvement of the lumen diameter of carotid arteries in   show the rest ...
Sample Size 320 patients, 50 sites
Data Collection The primary long-term endpoint is a composite of any death, stroke and myocardial infarction at   show the rest ...
Followup Visits and Length of Followup Annual follow-up through 3 years. No descriptions of enrollment and/or measures for handling follow-up are   show the rest ...
Final Study Results
Actual Number of Patients Enrolled A total of 322 patients have been enrolled into the study.
Actual Number of Sites Enrolled There are a total of 38 study sites that enrolled patients.
Patient Followup Rate Follow-up rate is 75.2% (242/322).
Final Safety Findings

1) A total of six clinically driven target revascularization (TLR) events were reported in five patients.   show the rest ...
Final Effectiveness Findings

The primary endpoint was a composite of DSMI at 30 days, plus ipsilateral stroke between   show the rest ...
Study Strengths and Weaknesses Strength:

The study provides long term follow-up of patients at high risk for adverse events   show the rest ...
Recommendations for Labeling Changes

Yes, labeling will be updated with the 3-year data.



PROTECT Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 03/06/2006 04/04/2006 Overdue/Received
1 year report 09/06/2006 09/06/2006 On Time
18 month report 03/07/2007 03/08/2007 Overdue/Received
2 Year Report 09/06/2007 08/27/2007 On Time
30 month report 03/07/2008 02/29/2008 On Time
3 Year Report 09/05/2008 06/30/2008 On Time
42 month report 03/07/2009 02/24/2009 On Time
4 Year Report 02/02/2010 02/01/2010 On Time
54 month report 03/07/2010 02/23/2010 On Time
5 Year Report 09/05/2010 09/03/2010 On Time
66 month report 03/06/2011 03/04/2011 On Time
6 year report 09/05/2011 09/06/2011 Overdue/Received
78 month report-FINAL REPORT 03/05/2012 12/12/2011 On Time

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