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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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EMERGE


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General
Application Number P070012 / PAS002
Current Plan Approved 10/23/2007
Study Name EMERGE
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The primary objective of the EMERGE study is to evaluate the safety of the Exponent Carotid Stent System with distal embolic protection in routine clinical practice for the treatment of carotid stenosis in patients at high risk for carotid endarterectomy and to identify rare or unanticipated device-related events that might occur with use of the devices.
Study Population Description This device is indicated for use, in conjunction with a Medtronic Vascular embolic protection system, for improving carotid luminal diameter in patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the following criteria: 1) neurological symptoms and > 50% stenosis of the common or internal carotid artery by either ultrasound or angiogram, or patients without neurological symptoms and > 80% stenosis of the common or internal carotid artery by either ultrasound or angiogram, and 2) having a vessel with reference diameters between 4.5 mm and 9.5 mm at the target lesion.
Sample Size 1500 patients, 50 sites
Data Collection The protocol defined primary endpoint for each phase of the trial was the cumulative incidence of major adverse events at 1-year, defined as a composite of all-cause death, MI (Q wave and non-Q wave), and ipsilateral stroke. The primary endpoint is defined as the cumulative incidence of major adverse events at 1-year post-procedure, defined as all-cause death, stroke, or MI at 30 days plus all-cause death, MI or ipsilateral stroke within 31 days to 365 days post-procedure.
Follow-up Visits and Length of Follow-up All patients will be followed to 30 days, the first 500 patients will be followed for 365 days.
Final Study Results
Interim Safety Information None, no patients were ever enrolled in this study
Number of Patients 0
Number of Sites 0
Follow-up Rate Not applicable
Safety Findings None, study was never started.
Strengths & Weaknesses None, study was not conducted.
Label Changes No labeling changes recommended since study was not conducted.




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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