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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 P060033
Most Recent Protocol Version Approved 02/01/2008
Study Name 5yr Clinical Outcomes
Study Status Completed
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is design to obtain long term follow-up of the premarket study cohort patients.
Study Population Description This device is indicated for improving coronary luminal diameter in patients with ischemic heart disease   show the rest ...
Sample Size Endeavor I: 100 patients, 8 sites; Endeavor II: 1197 patients, 72 sites; Endeavor II CA:   show the rest ...
Data Collection Endeavor IV: The primary endpoint was target vessel failure at 9 months post-procedure.
Followup Visits and Length of Followup Annually to five years
Final Study Results
Actual Number of Patients Enrolled Overall, there are a total of 3,621 patients enrolled for Endeavor trials.
Actual Number of Sites Enrolled Overall, there are a total of 210 study sites enrolling patients for Endeavor trials (I,   show the rest ...
Patient Followup Rate 60-month follow-up is complete on 97%, 96.8%, 96.9%, 88%, 93%, and 100% of patients enrolled   show the rest ...
Final Safety Findings The cumulative 5-year MACE rates were 7.2% (7/97), 15.4% (89/577), 17.8% (51/287), 14.0% (43/307), 17.9%   show the rest ...
Final Effectiveness Findings The cumulative 5-year TVF rates were 5.2% (5/97), 15.4% (89/577), 21.6% (62/287), 17.9% (55/307), 17.3%   show the rest ...
Study Strengths and Weaknesses Strength:

The follow-up rates for all Endeavor trials meet the requirement of 80% specified in the   show the rest ...
Recommendations for Labeling Changes Labeling changes are being requested.


5yr Clinical Outcomes Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year report 01/31/2009 01/27/2009 On Time
2 year report 01/31/2010 01/29/2010 On Time
3 year report 01/31/2011 01/27/2011 On Time
4 year report-final report 01/31/2012 01/13/2012 On Time
response to R19 RDEF final report 05/12/2012 05/11/2012 On Time

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