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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 P070015
Most Recent Protocol Version Approved 07/02/2008
Study Name Longterm IDE Follow up
Study Status Progress Adequate
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 Adult: >21
Detailed Study Protocol Parameters
Study Design Description Approximately 1125 subjects were originally planned to be enrolled in the study; however, the study   show the rest ...
Study Population Description This device is indicated for improving coronary luminal diameter in patients with symptomatic heart disease   show the rest ...
Sample Size SPIRIT FIRST: 60 patients, 9 sites, SPIRIT II: 300 patients, no site maximum specified, SPIRIT   show the rest ...
Data Collection The primary endpoint of the SPIRIT FIRST clinical study was in-stent LL at 180 days   show the rest ...
Followup Visits and Length of Followup SPIRIT FIRST: Patients were evaluated at 30, 180, 270 days and 1, 2, and 3   show the rest ...
Final Study Results
Actual Number of Patients Enrolled SPIRIT FIRST: 60

SPIRIT II: 300

SPIRIT III (RCT): 1002

SPIRIT III (4.0mm size): 73

SPIRIT IV: 3687

  show the rest ...
Actual Number of Sites Enrolled SPIRIT FIRST: 9

SPIRIT II: 28

SPIRIT III (RCT): 65

SPIRIT III (4.0mm size): 30

SPIRIT IV: 66

  show the rest ...
Patient Followup Rate SPIRIT FIRST: 87% SPIRIT II: 81%

SPIRIT III (RCT): 84.3% SPIRIT III (4.0mm size): 88% SPIRIT   show the rest ...
Final Safety Findings SPIRIT FIRST

No stent thrombosis events reported in either arm in the SPIRIT FIRST study through   show the rest ...
Final Effectiveness Findings SPIRIT FIRST

The five-year follow-up rates of TVF remained favorable in the XIENCE V arm, 16.7%   show the rest ...
Study Strengths and Weaknesses Results from each of the five clinical studies for XIENCE V® including: SPIRIT FIRST, SPIRIT   show the rest ...
Recommendations for Labeling Changes Post-approval study findings from each of the five clinical studies for XIENCE V® including: SPIRIT   show the rest ...


Longterm IDE Follow up Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year report 02/26/2009 02/12/2010 On Time
2 year report 07/02/2010 06/29/2010  
3 year report 07/02/2011 04/22/2011 On Time
unsolicited report 06/13/2012 06/13/2012 On Time
3 year follow-up report 06/25/2012 06/25/2012 On Time
4 year report 07/01/2012 01/17/2012 On Time
final report for SPIRIT III and SPIRIT IV 07/01/2013 05/01/2013 On Time
three year follow up report 08/20/2013 08/20/2013 On Time

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