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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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Application Number P060001 / PAS002
Current Plan Approved 08/02/2007
Study Name CREATE (IDE)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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.
Follow-up Visits and Length of Follow-up Follow-Up Schedule: Pre-discharge, 1 month, 6 months (phone only), 1, 2, and 3 years post study procedure.
Final Study Results
Interim Safety Information Study completed, see final results.

CREATE (IDE) Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
Final Report 04/17/2009 04/08/2009 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

Phone: (301) 796-6134
Fax: (301) 847-8140

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