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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 P110001
Current Protocol Accepted 06/26/2012
Study Name HERCULES PAS
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 No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The HERCULES trial is a prospective, non-randomized, multi-center, single-arm clinical trial to demonstrate efficacy and   show the rest ...
Study Population Description The population is entirely comprised of the existing 202-patient HERCULES study cohort.
Sample Size The sample size and power calculation were based on the primary endpoint of binary restenosis   show the rest ...
Data Collection ¿ Major Adverse Events: (death, nephrectomy, embolic events resulting in kidney damage) reported for all follow   show the rest ...
Followup Visits and Length of Followup 36 months

12 months (+/- 6 weeks)

Physician office visit: Blood pressure measurement, antihypertensive medication review, identification   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 202
Actual Number of Sites Enrolled 37
Patient Followup Rate 73%
Final Safety Findings The binary restenosis rate at 9 months was 10.5% (22/209), with the upper one-sided 95%   show the rest ...
Final Effectiveness Findings 3 year rates:

¿The freedom from TLR Kaplan-Meier Survival Analysis was 87.6%.

¿The study device, procedure, and   show the rest ...
Study Strengths and Weaknesses Strengths ¿ Outcome well below performance goal

Weakness - High attrition rate (27%).

Recommendations for Labeling Changes yes


HERCULES PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 01/18/2012 01/23/2012 Overdue
one year report 07/19/2012 07/18/2012 On Time
18 month report 01/17/2013 01/04/2013 On Time
two year report-FINAL 07/19/2013 04/08/2013 On Time

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