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 PAS is a prospective, multi‐center, non‐randomized, single arm study with sequential enrollment of all
qualified subjects undergoing treatment of atherosclerotic lesions in the native superficial femoral artery or the superficial femoral and proximal popliteal arteries. All eligible subjects who provide informed consent will undergo PTA and stenting using the EverFlex device. Follow‐up will take place at pre‐ discharge, 30 days, 1 year, 2 years and 3 years.
Study Population Description
Adult patients with lesions no greater than 180 mm in length in the native superficial
femoral artery or the superficial femoral and proximal popliteal arteries, who do not meet any of the exclusion criteria for this device.
The sample size of 113 is driven by the need for the above noted precision
confidence interval for stent fracture rate. This sample size will ensure precision of the stent fracture rate at 1 year with a 95% confidence interval of 1.3% to 7.9%, assuming a proportion of 4.6% and 10% attrition at 1 year. Also, assuming that the true 36‐month composite primary endpoint rate is 55% (with a performance goal of greater than 35%) and 30% attrition at 36 months, the resulting 118 evaluable subjects are greater than the 79 required to power the primary endpoint.-
Twenty (20) to 30 sites will be used in the study.
Primary endpoints A composite endpoint defined as freedom from acute death, freedom from 36‐month amputation, and
freedom from 36‐month clinically‐ driven target lesion revascularization
Secondary endpoints Freedom from stent fracture at 1, 2, and 3 years Freedom from 36‐month amputation at 1, 2, and 3 years Freedom from 36‐month clinically driven target lesion revascularization at 1, 2, and 3 yrs Freedom from acute death (within 30 days of the procedure) Device success - ability to employ the device as intended Improvement in Rutherford clinical category at one year Improvement in ankle‐brachial index at one year Walking improvement at one year Adverse events, including all cause mortality
Followup Visits and Length of Followup
Follow‐up visits will occur pre‐discharge, at one month, at one year, and annually thereafter, up