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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 P070015 S054
Most Recent Protocol Version Approved 05/24/2011
Study Name SPIRIT Small Vess (SV) Registry
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
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs
Detailed Study Protocol Parameters
Study Design Description Prospective, single-arm, open-label, US multi-center registry study to evaluate the safety and effectiveness of the   show the rest ...
Sample Size 150 subjects enrolled at up to 75 sites in the United States
Data Collection The primary endpoint is the composite rate of cardiac death, target vessel myocardial infarction (MI)   show the rest ...
Followup Visits and Length of Followup Clinical F/U: 30 days (clinic visit), 240 days and 1 year (clinic visit), 2, 3,   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 150
Actual Number of Sites Enrolled 33
Patient Followup Rate 84%
Final Safety Findings The overall (0 - 1123 days) definite/probable stent thrombosis rate per ARC was 1.5% (2/130).
Final Effectiveness Findings -MACE Rates at 3 years: 12.1% (16/132)

-TVR rates at 3 years: 13.6% (18/132)

-TLF rates at   show the rest ...
Study Strengths and Weaknesses Results provide further evidence of the clinical utility and safety of this device. The study   show the rest ...
Recommendations for Labeling Changes A labeling change is recommended to add a summary of the post-approval study results including   show the rest ...


SPIRIT Small Vess (SV) Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
one year report 11/22/2011 12/21/2011 Overdue/Received
two year report 05/23/2013 02/12/2013 On Time
three year report-final report 05/23/2014 06/28/2013 On Time

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