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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 P120002
Current Protocol Accepted 11/07/2012
Study Name STROLL Post Approval Study
Study Status Progress Adequate
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 Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description A non-randomized, multicenter, prospective, single- arm study.
Study Population Description Patients enrolled in the pivotal STROLL study who received the S.M.A.R.T. Nitinol Self-Expandable Stent. There   show the rest ...
Sample Size 39 sites in the United States. A total of evaluable subjects at 3 year follow-up.
Data Collection Primary safety endpoint: A composite of all-cause death, amputation and target lesion revascularization (TLR) at   show the rest ...
Followup Visits and Length of Followup No new enrollments are planned for the post-approval study.

3 years following index procedure.

  show the rest ...
Final Study Results
Actual Number of Patients Enrolled 250
Actual Number of Sites Enrolled 39
Patient Followup Rate 90.9% (190/209) [209 = number of patients eligible for 3 year visit]



Final Safety Findings At 3 years the composite endpoint death, index limb amputation, or clinically driven TLR was   show the rest ...
Final Effectiveness Findings At 3 years the composite endpoint death, index limb amputation, or clinically driven TLR was   show the rest ...
Study Strengths and Weaknesses The study achieved a high follow-up rate of about 91% at 3 year, with enough   show the rest ...
Recommendations for Labeling Changes Labeling change is recommended to reflect the long term data from the post-approval study. The   show the rest ...


STROLL Post Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
two year clinical report 12/10/2012 12/10/2012 On Time
Final Report 11/07/2013 08/26/2013 On Time
two year report 11/07/2014    
three year report 11/07/2015    
four year report 11/06/2016    
five year report 11/06/2017    

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