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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 P110013
Current Protocol Accepted 02/17/2012
Study Name OSB Lead-Cont Followup of Premarket and OUS Cohort
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 No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description These analyses will utilize the pooled data from the Global RESOLUTE Clinical Trial Program on-label   show the rest ...
Study Population Description The study population consists of four studies (R-FIM, R-AC, R-US, and R-J) with a five-year   show the rest ...
Sample Size Within the on-label subjects, a sample size of 1,312 will have 80% power to demonstrate   show the rest ...
Data Collection Primary Endpoint

ARC definite or probable ST rates from 12-24, 24-36, 36-48 and 48-60 months.



CD/TVMI annual   show the rest ...
Followup Visits and Length of Followup Data collection will be annually up to 5 years of follow-up, except for R-Int (36 months)
Final Study Results
Actual Number of Patients Enrolled 2,017 on-label subjects

764 complex subjects

Actual Number of Sites Enrolled RESOLUTE All Comers (R-AC): 17 sites

RESOLUTE initial feasibility trial (R-FIM): 12 sites

RESOLUTE Japan (R-J): 14   show the rest ...
Patient Followup Rate On-label: 96% (1937/2017) Complex: 98% (751/764)
Final Safety Findings Objective 1:

The annual rate of Academic Research Consortium (ARC)-defined definite and probable stent thrombosis (ST)   show the rest ...
Final Effectiveness Findings Procedural success: 97.9% (1961/2003)

Device success: 98.3% (2251/2289)

Lesion success: 99.9% (2283/2285)

  show the rest ...
Study Strengths and Weaknesses This study provides longer term (5 years) safety and effectiveness results of the Resolute Zotarolimus-   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 ...


OSB Lead-Cont Followup of Premarket and OUS Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
one year report 02/16/2013 03/27/2012 On Time
two year report 02/16/2014 03/29/2013 On Time
three year report 03/31/2014 03/31/2014 On Time
four year report 03/31/2015 03/30/2015 On Time
final report 06/15/2015 06/15/2015 On Time

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