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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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CABERNET Registry


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General
Application Number P050025 / PAS001
Current Plan Approved 10/12/2006
Study Name CABERNET Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The primary objective of the study was to determine whether morbidity and mortality for high-risk surgical patients treated with the NexStent Over the Wire in conjunction with the FilterWire EXIEZ System Distal Protection Device will be less than an Objective Performance Criterion derived from historic controls undergoing surgical intervention with carotid endarterectomy.
Study Population Description The NexStent Carotid Stent System used in conjunction with the FilterWire EZ System, is indicated for treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below 1) Patients with neurological systems associated with >50% stenosis of the common or internal carotid artery OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram AND 2) Patients must have a reference vessel diameter within the range of 4 mm and 9 mm at the target lesion and a stenosis less than 30 mm in length. The subject population being studied included subjects indicated for NexStent Carotid Stent System placement.
Sample Size 488 patients including 454 registry patients and 34 Roll-In patients, 21 sites
Data Collection Primary safety endpoints include: 1) Major clinical events at one-year defined as any death, stroke or myocardial infarction, and 2) 30 day event rate defined as any death, stroke or myocardial infarction at 30 days post-procedure. 12 month event rate defined as the 30 day event rate plus any ipsilateral stroke and/or death as a result of an ipsilateral stroke.
Follow-up Visits and Length of Follow-up Follow-up at 30 days and one year post procedure
Final Study Results
Interim Safety Information Study completed, see final results.
Number of Patients 488 patients
Number of Sites 21 sites
Follow-up Rate 86%
Safety Findings On June 6, 2008, BSC initiated a voluntary recall of all units of the NexStent Carotid Stent System due to reported complaints involving detachment of the tip from the stent delivery System.
Strengths & Weaknesses Strengths: The post-approval study was able to detect an early problem involving detachment of the tip from the stent delivery system. Weaknesses: There was no predetermined hypothesis for postapproval analysis.
Label Changes Nexstent carotid stent was taken off the market due to adverse events that have occurred as part of the SONOMA post-approval study. Labeling changes were not recommended since the device is no longer marketed.


CABERNET Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
2 Final Report 10/27/2008 10/27/2008 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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