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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
This study will 1) evaluate clinical outcomes in a cohort of real-world patients receiving the
XIENCE V EECSS during commercial use by various physicians with a range of coronary stenting experiences; 2) Evaluate patient compliance with adjunctive antiplatelet therapy and major bleeding complications;3) Determine clinical device and procedural success during commercial use; and 4) Evaluate patient health status using the Seattle Angina Questionnaire.
Study Population Description
The XIENCE V Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter
in patients with symptomatic heart disease due to de novo native coronary artery, lesions (length < 28 mm) with reference vessel diameters of 2.5 mm to 4.25 mm.
Sample Size
5000 patients, number of sites not listed
Data Collection
The primary endpoints of the study are is stent thrombosis rates annually through 5 years
as defined by Academic Research Consortium and the composite rate of cardiac death and any myocardial infarction at 1 year.
Followup Visits and Length of Followup
Clinical follow-up for this cohort will occur at 2, 3, 4, and 5 years.
