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 study is designed to provide long term follow-up of the CREATE Pivotal Study population.
The CREATE Study was a prospective multi-center, non-randomized studies in which consecutive qualifying subjects undergoing carotid interventional procedures were enrolled. The primary objective of the CREATE Pivotal study was to evaluate the safety and efficacy of the PROTEGE Stent and Spider Device in the treatment of common and/or internal carotid artery stenoses for subjects at high risk for adverse events from carotid endarterectomy.
Study Population Description
This device is indicated for the treatment of patients at high risk for adverse events
from carotid endarterectomy who require percutaneous carotid revascularization and meet the criteria outlined below: 1) patients with carotid artery stenosis (> 50% for symptomatic patients by ultrasound or angiography or > 80% for asymptomatic patients by ultrasound or angiography) of the common or internal carotid artery, and b) patients must have a reference vessel diameter within the range of 4.5 mm and 9.5 mm at the target lesion.
Sample Size
419 patients, 31 sites
Data Collection
The primary endpoints were MI, ipsilateral cerebral vascular accident, procedure-related contralateral cerebral vascular accident, or
death within 30 days of implantation; and ipsilateral cerebral vascular accident from 31 days to 1 year post-implantation.
Followup Visits and Length of Followup
Follow-Up Schedule: Pre-discharge, 1 month, 6 months (phone only), 1, 2, and 3 years post
study procedure.
Final Study Results
Actual Number of Patients Enrolled
419 patients
Actual Number of Sites Enrolled
31 sites
Patient Followup Rate
66%
Final Safety Findings
The primary endpoint composite 30-day MACCE rate was 6.3%. The secondary endpoint of Technical was
observed in 97.4% of subjects enrolled in the CREATE Pivotal Study. The most frequently observed serious adverse event during this time was transient procedural hypotension (18.0%). Hypotension was the most frequently reported serious adverse event through the three-year time point. The overall 30-day non-serious adverse event rate was 7.2%. The primary endpoint rate of this study was evaluated against a pre-defined objective performance criterion of 16%. The observed rate in the study of 5.3% is well below this threshold. The primary endpoint rate was not calculated on the 3 year cohort. The serious adverse events were adjudicated by a Clinical Events Committee. The total device-related serious adverse event rate at 3 years was 5.9%.
Recommendations for Labeling Changes
No labeling changes are recommended at this point. A labeling change based on the extended
follow-up of the premarket cohort is not suggested until the post-approval study is completed.
