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.
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
A prospective, single-arm, multi-center study. Includes all subjects from the new US enrollment study, the
Zilver PTX subjects from the premarket study, the Japanese post-approval study.
Study Population Description
Comprises of PAS 1 subjects, the Zilver PTX subjects from the pivotal study, and earliest
sequentially enrolled subjects in the Japan PAS that are consistent with the US PAS selection criteria with the exception that lesion length per limb may extend up to 200 mm.
Patients with symptomatic vascular disease of the native above-the-knee femoropopliteal arteries with a reference vessel diameter 4 to 7 mm and total lesion lengths up to 140 mm per limb and 280 mm total will be enrolled; for patients enrolled from the Japan PAS, lesion length per limb may extend up to 200 mm.
The sample size will comprise of 200 patients from the new US Enrollment enrolled from
minimum of 10 sites, 300 premarket RCT patients enrolled at 47 sites in the US, and approximately 400 patients from the Japan postmarket study enrolled at 60-90 sites.
Target lesion revascularization (TLR), patency by duplex ultrasonography, and stent thrombosis assessed annually through 5
years in 900 subjects.
Stent integrity assessed by x-ray imaging at 1, 3, and 5 years in 600 patients.