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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 P100040
Current Protocol Accepted 09/14/2011
Study Name Captivia Delivery System
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 New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multi-center, single-arm study to assess the freedom from ARM at five years.
Study Population Description The study involves follow-up of the VALOR II cohort. Criteria for being in this study   show the rest ...
Sample Size Based on the need for a statistical power of 80%, using a one-sided 95% confidence   show the rest ...
Data Collection Primary Endpoint

The primary endpoint of the study is aneurysm-related mortality at five years, defined as:



Death   show the rest ...
Followup Visits and Length of Followup Five years
Final Study Results
Actual Number of Patients Enrolled 160
Actual Number of Sites Enrolled 28
Patient Followup Rate 94%
Final Safety Findings The majority of aneurysms at all time periods either decrease in size or show no   show the rest ...
Final Effectiveness Findings Five year aneurysm related mortality rate, by KM analysis is 94.8% (with a lower 95%   show the rest ...
Study Strengths and Weaknesses Strength: Prospective study

Device met its performance goal by a large margin (lower bound of 95% confidence   show the rest ...
Recommendations for Labeling Changes A change in labeling is recommended to update the results of the PAS.


Captivia Delivery System Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 09/30/2011 09/28/2011 On Time
one year report 03/31/2012 03/29/2012 On Time
18 month report 09/29/2012 09/28/2012 On Time
two year report 03/31/2013 03/26/2013 On Time
three year report 03/31/2014 03/27/2014 On Time
four year report-final report 03/31/2015 01/23/2015 On Time

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