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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P060001 / PAS001 |
| Date Original Protocol Accepted |
08/02/2007
|
| Date Current Protocol Accepted |
08/02/2007
|
| Study Name |
CREATE PAS
|
| Device Name |
PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
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 |
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.
|
| Sample Size |
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.
|
| Key Study Endpoints |
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.
|
| Follow-up Visits and Length of Follow-up |
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
|
| Interim or Final Data Summary |
| Interim Results |
The primary analysis of the one-year cohort is an assessment of Major Adverse Cardiac and Cerebrovascular Events, defined as the combined incidence of death, myocardial infarction, ipsilateral cerebrovascular accident and procedure-related contralateral cerebrovascular accident through 30 days post implantation. It also includes an assessment of ipsilateral cerebrovascular accident from 31 days to one year post-implantation when subjects have reached that stage of follow-up. The secondary analysis includes a presentation on the primary analysis stratified by the implanting physician's experience level. The death rate for the 1-year cohort at 30 days was 3%. The MI rates for the 1-year cohort at 30 day was 1.2%. The procedure-related contralateral cerebrovascular accident rate for the 1-year cohort was 0% and the ipsilateral cerebrovascular accident at 1-year was 0.4%.
|
| Actual Number of Patients Enrolled |
1,500
|
| Actual Number of Sites Enrolled |
57
|
| Patient Follow-up Rate |
93% (1,400/1,500)
|
| 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 Effect 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 & 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.
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| Recommendations for Labeling Changes |
yes
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