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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 P060008 S011
Current Protocol Accepted 07/23/2010
Study Name TAXUS Long (S011)
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 Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multi-center study designed to observe clinical outcomes in patients receiving the   show the rest ...
Study Population Description The TAXUS Liberté Long Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel tube with   show the rest ...
Sample Size 84 subjects, 100 sites
Data Collection Data will be collected on the rate of cardiac death or myocardial infarction through 12   show the rest ...
Followup Visits and Length of Followup Patient follow up will occur at months 6, 12, 15, 18, 24, 30, 33, 36,   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 150
Actual Number of Sites Enrolled 24
Patient Followup Rate 90.2%
Final Safety Findings ¿MACE: out-of-hospital MACE to 5 years was comparable for the groups (32.6% for the TAXUS®   show the rest ...
Final Effectiveness Findings ¿MACE (cardiac death, MI, and TVR): The rate at 5 years was comparable between the   show the rest ...
Study Strengths and Weaknesses Sponsor had a high follow-up rate. The stent thrombosis rate was higher in the treatment   show the rest ...
Recommendations for Labeling Changes Yes, to update with the five year final study results.


TAXUS Long (S011) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 01/11/2010 02/03/2010 Overdue/Received
18 month report 01/11/2011 11/26/2010 On Time
2 year report 07/13/2011 06/01/2011 On Time
3 year report-FINAL REPORT 07/12/2012 12/16/2011 On Time

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