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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
Current Protocol Accepted 10/10/2008
Study Name Outcomes TAXUS ATLAS
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 multicenter, single-arm trial to evaluate the safety and efficacy of the TAXUS

Liberte   show the rest ...
Study Population Description This device is indicated for improving luminal diameter for the treatment of de novo lesions   show the rest ...
Sample Size 822 patients, 60 sites
Data Collection The primary endpoint of the study was ischemia-driven target vessel revascularization at 9-month follow-up. The   show the rest ...
Followup Visits and Length of Followup Patient follow-up was planned annually for 5 years post-index procedure.
Final Study Results
Actual Number of Patients Enrolled 867
Actual Number of Sites Enrolled 60
Patient Followup Rate 91.7%
Final Safety Findings The MACE (cardiac death, MI, and TVR) rate at 5 years post stent implantation was   show the rest ...
Final Effectiveness Findings See above
Study Strengths and Weaknesses Despite greater lesion complexity in the TAXUS ATLAS Group, the 5 year post implantation data   show the rest ...
Recommendations for Labeling Changes The 1461-1855 day stent thrombosis rate was 2.4% in the TAXUS ATLAS group and 0%   show the rest ...


Outcomes TAXUS ATLAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year report 10/10/2009 08/14/2009 On Time
2 year report 10/10/2010 05/05/2010 On Time
Final Report 10/10/2011 10/18/2010 On Time

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