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 is a prospective, multi-center study designe to further understand Endeavor stent treatment patterns and
clinical outcomes in broad, unselected patient populations in North America, and 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. Study subjects with ischemic heart disease due to stenotic lesions in either native coronary arteries or coronary artery bypass grafts undergoing percutaneous coronary intervention with stent placement are eligible to be enrolled in this study. Subjects may have multi-vessel treatment. Patients eligible for randomization into the CPI should not have contraindications to prolonged dual antiplatelet therapy noted at the time of randomization.
Sample Size
A minimum of 2,000 patients and a maximum of 4,000 patients, 100-150 sites
Data Collection
Endpoints that will be analyzed include: 1) definite and probable stent thrombosis at one year;
2) Combined rate of cardiac death and MI at one year; 3) Composite of death, target vessel MI, stroke, and major bleeding (severe or moderate per GUSTO classification) at one year; and 4) dual antiplatlet therapy compliance rates at each follow up interval to one year.
Followup Visits and Length of Followup
Patients will be followed at 3 , 6, 9, 12, 15, 18, 24, 30, and
33 months. The 12 month and 30 month follow-up include a clincal visit, 6, 9, 15, 18, 24, and 33 month follow-up involves telephone follow-up.
