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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 P050025
Current Protocol Accepted 10/12/2006
Study Name CABERNET Registry
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 Concurrent Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The primary objective of the study was to determine whether morbidity and mortality for high-risk   show the rest ...
Study Population Description The NexStent Carotid Stent System used in conjunction with the FilterWire EZ System, is indicated   show the rest ...
Sample Size 488 patients including 454 registry patients and 34 Roll-In patients, 21 sites
Data Collection Primary safety endpoints include: 1) Major clinical events at one-year defined as any death, stroke   show the rest ...
Followup Visits and Length of Followup Follow-up at 30 days and one year post procedure
Final Study Results
Actual Number of Patients Enrolled 488 patients
Actual Number of Sites Enrolled 21 sites
Patient Followup Rate 86%
Final Safety Findings On June 6, 2008, BSC initiated a voluntary recall of all units of the NexStent   show the rest ...
Study Strengths and Weaknesses Strengths: The post-approval study was able to detect an early problem involving detachment of the   show the rest ...
Recommendations for Labeling Changes Nexstent carotid stent was taken off the market due to adverse events that have occurred   show the rest ...


CABERNET Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
2 Final Report 10/27/2008 10/27/2008 On Time

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