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, multicenter, single- arm, non-randomized study.
Study Population Description
Subjects with lifestyle-limiting claudication or ischemic rest pain attributable to lesion(s) in the infra-inguinal segment
and/or proximal popliteal artery that are amenable to PTA and stenting.
The control group is historical cohorts of RESILIENT PTA group
Sample Size
Subjects will be enrolled at 25 study sites within the USA
A minimum of 234 subjects:
at least 64 subjects with target lesion lengths < 160 mm; at least 64 subjects with target lesion lengths > 160 mm and < 240 mm and at least 64 subjects treated with the 200 mm LifeStent will be enrolled.
Data Collection
The Primary Safety endpoint is freedom from occurrence of death at 30-days and 12-months post-index
procedure.
The Primary Effectiveness is device success defined as freedom from acute delivery failure, and primary target lesion patency (TLP) at 12 months post index procedure.
Freedom from Fracture (FFF)
Followup Visits and Length of Followup
Subjects will be followed for 36 months
Subjects will undergo clinical assessments at 30 days, 12,
