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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 S008
Current Protocol Accepted 07/23/2009
Study Name TAXUS ATLAS Small Vessel
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, multi-center study designed to observe clinical outcomes in patients receiving the   show the rest ...
Study Population Description The TAXUS Liberté Atom (2.25 mm) Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel   show the rest ...
Sample Size 168 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 261 TAXUS ATLAS patients, 75 DES control, 155 BMS control
Actual Number of Sites Enrolled 23
Patient Followup Rate 91.3% TAXUS ATLAS, 90.4% DES Control, 85.5% BMS Control. These percentages include patients who died   show the rest ...
Final Safety Findings MACE (cardiac death, MI, and TVR): The rate at 5 years was 26.3 in the   show the rest ...
Final Effectiveness Findings TVR, TLR and TVF rates at 5 years were 20.1%, 13.4% and 25.6%, respectively, for   show the rest ...
Study Strengths and Weaknesses The sponsor present a well designed study with a control group with good follow-up at 5 years.
Recommendations for Labeling Changes Updated to include the long-term post-approval study data and findings.


TAXUS ATLAS Small Vessel Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
Clinical Outcomes Report 09/21/2009 09/18/2009 On Time
2 year report 05/21/2011 11/24/2010 On Time
3 year report 05/20/2012 05/18/2011 On Time
4 year report-FINAL REPORT 05/20/2013 12/09/2011 On Time

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