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.
The ENDEAVOR North America is a prospective, multi-center study intended to enroll a minimum of
2,000 subjects and a maximum of 4,000 subjects at up to 100 ¿ 150 clinical sites in the US and Canada. The objective of this study is: 1) To further understand Endeavor stent treatment patterns and clinical outcomes in broad, unselected patient populations in North America; and 2) To understand North American physician prescription patterns of dual antiplatelet therapy and implications of compliance with dual antiplatelet therapy.
Study Population Description
This device is indicated for improving coronary luminal diameter in patients with ischemic heart disease
due to de novo lesions of length < 27mm in native coronary arteries with reference vessel diameters of > 2.5mm to < 3.5 mm.
4,000 patients at 100-150 sites
The primary endpoint is stent thrombosis and cardiac death plus myocardial infarction at 1 year.