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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 P030025 S028
Current Protocol Accepted 09/24/2008
Study Name 5 year Clinical Outcomes
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 This is a prospective, randomized, controlled, multicenter, double-blind safety and efficacy study. Patients were randomized   show the rest ...
Study Population Description The device is indicated for improving luminal diameter for the treatment of de novo lesions   show the rest ...
Sample Size 1172 patients (86 in the TAXUS group and 586 in the Control group), 66 sites
Data Collection The primary endpoint is the rate of ischemia-driven target vessel revascularization at 9 months after   show the rest ...
Followup Visits and Length of Followup Patients will be follow for 5 years post procedure. A subset of patients will have   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 421
Actual Number of Sites Enrolled 37
Patient Followup Rate 86.3%
Final Safety Findings Through 5 years of follow-up, the safety profile of the TAXUS group demonstrated better MACE   show the rest ...
Final Effectiveness Findings Between 4 and 5 years, the rates of TVR (6.7% Brachytherapy, 5.5% TAXUS; P=0.6267) and   show the rest ...
Study Strengths and Weaknesses Sponsor demonstrated adequate follow-up out to 5 years. The results do not raise any safety   show the rest ...
Recommendations for Labeling Changes Updated labeling to include ISR 5 year study results.


5 year Clinical Outcomes Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
3 year data report 11/10/2008 11/10/2008 On Time
1 Year Report (4 year data) 06/25/2009 06/25/2009 On Time
Final Reportr 06/15/2010 06/15/2010 On Time

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