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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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CREATE PAS


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General
Application Number P060001 / PAS001
Current Plan Approved 08/02/2007
Study Name CREATE PAS
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 Design Description 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.
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.
Data Collection 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
Final Study Results
Interim Safety Information 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%.
Number of Patients 1,500
Number of Sites 57
Follow-up Rate 93% (1,400/1,500)
Safety Findings In the total cohort, the death rate was ... The one-year serious adverse event rate was ... in the one-year PAS cohort.
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.
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.
Label Changes yes


CREATE PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 07/25/2007 07/23/2007 On Time
1 year report 01/24/2008 01/18/2008 On Time
18 month report 07/24/2008 07/31/2008 Overdue/Received
2 year report 01/23/2009 01/27/2009 Overdue/Received
3 year report 01/23/2010 01/21/2010 On Time
48 month report 01/21/2011 01/21/2011 On Time
4 year Report 01/23/2012 01/23/2012 On Time
Final Report 04/25/2012 04/25/2012 On Time
unsolicited report 01/22/2013 01/22/2013 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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