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.
This is a prospective, multi-site, non-randomized study in which consecutive qualifying subjects undergoing carotid interventional
procedures are enrolled. No formal statistical hypothesis testing will be conducted, except for the sequential monitoring against a predefined criteria for rate of events, which will be carried out by the Clinical Events Committee.
Study Population Description
The PROTÉGÉ Stent will be implanted in stenoses in the common and/or internal carotid artery
in subjects with a high risk for complications during carotid endarterectomy. The interventional procedure will be performed with the SpiderFX Device that is intended to reduce the risk of distal embolization during percutaneous carotid interventions.
A total of xx subjects in two cohorts will be enrolled into the study. The
first 500 subjects will be enrolled in the one-year cohort and will be followed for one year post-study procedure. The next 1000 subjects will be enrolled in the 30-day cohort and will be followed for 30 days post-study procedure. Up to 150 sites.
One-year Cohort: Subjects will be evaluated for the combined incidence of Major Adverse Cardiac and
Cerebrovascular Events defined as myocardial infarction ipsilateral cerebrovascular accident, procedure-related contralateral cerebrovascular accident, or death, within 30 days of implantation; and ipsilateral cerebrovascular accident from 31 days to one year post-implantation. 30-day Cohort: Subjects will be evaluated for the combined incidence of Major Adverse Cardiac and Cerebrovascular Events defined as myocardial infarction, ipsilateral cerebrovascular accident, procedure related contralateral cerebrovascular accident, or death, within 30 days of implantation.
Followup Visits and Length of Followup
Folllow-up for the One-year Cohort includes a pre-discharge visit, 30-day and one year clinic visits
and a telephone contact at six months post study procedure. Follow-up for the 30-day Cohort includes a pre-discharge visit, 30-day clinic visit post study procedure.
Length of follow-up: One year
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup Rate
Final Safety Findings
In the total cohort, the death rate was ... The one-year serious adverse event rate
was ... in the one-year PAS cohort.
Final Effectiveness Findings
The primary analysis of the one-year cohort is an assessment of Major Adverse Cardiac and
Cerebrovascular Events (MACCE), defined as the combined incidence of death, myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA) and procedure-related contralateral CVA through 30 days post-implantation. The rates found in the CREATE PAS for both the one-year and 30-day follow-up are both well below the % OPC used for the IDE study.
Study Strengths and Weaknesses
The sponsor attained over ... follow-up for the entire study. The study was not powered
to detect rare adverse events. The sponsor was also asked in the approval order to enroll patients from high, moderate and low volume centers and treated by physicians that represent Category 1, 2, and 3 training. The sponsor has done this; however the overwhelming majority of subjects were treated by physicians with level 1 experience. The low number of level 2 and level 3 operators makes it difficult to make any conclusions on the training program.