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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 P060002
Most Recent Protocol Version Approved 03/13/2008
Study Name FLAIR Endovascular Grafts
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective randomized study. One arm will receive balloon angioplasty of the target   show the rest ...
Study Population Description Patients with hemodynamically significant stenosis (>50%) with clinical evidence of graft dysfunction (without thrombotic occlusion)   show the rest ...
Sample Size 270 subjects, 30 sites
Data Collection Primary endpoints includ: 1) access Circuit Primary Patency (ACPP - defined as the interval following   show the rest ...
Followup Visits and Length of Followup Subject follow-up will occur at 30 days and 6, 12 and 24 months. Follow-up will   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 270
Actual Number of Sites Enrolled 35
Patient Followup Rate 98%
Final Safety Findings Subjects with device- or procedure-related AEs at 12 months: Control group ¡V 6%; FLAIR group   show the rest ...
Final Effectiveness Findings Primary endpoint # 1: Access Circuit Primary Patency (ACPP)

Time period ACPP for PTA ACPP for FLAIR

12   show the rest ...
Study Strengths and Weaknesses Strengths:

¿Þ Excellent follow-up (98%)

¿Þ Prospective cohort study

¿Þ Randomization to control vs. subject group

Weakness:

¿Þ Some measures   show the rest ...
Recommendations for Labeling Changes Yes: Update label with primary safety and effectiveness endpoints


FLAIR Endovascular Grafts Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year report 07/22/2008 07/21/2008 On Time
2 year report 07/23/2009 07/23/2009 On Time
3 year report 07/22/2010 07/22/2010 On Time
4 year report 07/22/2011 07/19/2011 On Time
5 year report 07/21/2012 09/28/2012 Overdue/Received
6 year report-final 07/22/2013 09/16/2013 Overdue/Received

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