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
The 38 mm Length Group is designed as a prospective analysis of the pooled data
from patients treated with a 38 mm stent from two multi-center, non-randomized studies, RESOLUTE US (R-US) and RESOLUTE Asia (R-Asia).
Study Population Description
Subjects enrolled in the Global Resolute Clinical Program
Sample Size
223 subjects (Consists of patients from 38 mm sub studies of R-US (N=114) and R-Asia (N=109))
Data Collection
Primary Endpoints
Stent Thrombosis rates from 12-24, 24-36, 36-48 and 48-60 months
Cardiac Death/TV MI annual rates
up to 5 years post procedure.
Followup Visits and Length of Followup
Patient Contact (assessed by telephone, email and/or office visit):
Annually 2, 3 years (R-Asia)*
Annually 2,
3, 4, 5 years (R-US)
Note: R-Asia patients were consented for 5 years. At 3 years if the event rates are demonstrated to plateau or decrease as compared to the rates in the prior years the Steering Committee and Sponsor may consider stopping further follow-ups.
Continued F/u of Premarket and OUS Cohort
Schedule
