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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 10/12/2005
Study Name EXACT Study
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 Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of the EXACT study is to collect clinical outcome and device performance data   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 1500 patients, 150 sites
Data Collection There are two primary composite endpoints defined in this study. The first primary composite endpoint   show the rest ...
Followup Visits and Length of Followup Patients were followed for 1-year. The endpoint of DSMI at 30 days and ipsilateral stroke   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 2232 patietns
Actual Number of Sites Enrolled 128 sites
Patient Followup Rate 85%
Final Safety Findings The composite event rate in the EXACT study (death, stroke, and myocardial infarction) of 4.1%   show the rest ...
Study Strengths and Weaknesses Strengths: The sponsor was able to achieve a greater than 90% follow up rate at   show the rest ...
Recommendations for Labeling Changes Updated labeling requested from sponsor to reflect myocardial infarction and stroke rates at 3 years.   show the rest ...


EXACT Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
Final EXACT Report 06/30/2008 06/27/2008 On Time

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