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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 P110019
Most Recent Protocol Version Approved 10/27/2011
Study Name XIENCE PRIME and XIENCE PRIME LL Everolimus Elut
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source Other Data Source
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Final Study Results
Actual Number of Patients Enrolled Core Size Registry (CSR) FAS: 401 subjects, ITT: 403 subjects

Long Lesion Registry (LLR) FAS: 104 subjects, ITT:   show the rest ...
Actual Number of Sites Enrolled 62
Patient Followup Rate CSR FAS: 94% (377/401), ITT: 93.8% (378/403) at 3 years

LLR FAS: 95.2% 99 (104), ITT:   show the rest ...
Final Safety Findings Core Size Registry (FAS population) endpoint rates observed through 3 years



All Death (Cardiac, vascular, non-cardiovascular) 3.1%   show the rest ...
Final Effectiveness Findings No separate effectiveness findings were reported.
Study Strengths and Weaknesses Strength: The study achieved a follow-up rate greater than 90% at 3 years.



Weakness: No formal   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 ...


XIENCE PRIME and XIENCE PRIME LL Everolimus Elut Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
one year report 10/31/2012 08/31/2012 On Time
two year report-final report 10/31/2013 05/24/2013 On Time

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