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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 P050025 / PAS002
Current Plan Approved 10/12/2006
Study Name SONOMA
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This was a nonrandomized, open-label study intended to confirm the safety of the NexStent

Carotid Stent System and the FilterWire EZ Embolic Protection System in routine clinical practice and to identify rare or unanticipated device-related events that may occur with the use of this system.
Study Population Description Study Population: 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 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. Indication: 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.
Sample Size 1650 patients, number of sites not specified
Data Collection The primary endpoints included 30-day rate of major adverse events defined as all deaths, strokes, and myocardial infarctions that occur within 0-30 days, 12-month composite rate of major adverse events, and ipsilateral stroke events that occur within 31-365 days for all subjects.
Follow-up Visits and Length of Follow-up Though 1,650 subjects were planned for the SONOMA study, only 298 had been enrolled at the point of study termination. Subjects were to be evaluated at 30 day and 12 month follow-up. As of July 24, 2009, the follow-up of all enrolled subjects (87.5%) was completed.
Final Study Results
Interim Safety Information See final results
Number of Patients 298 patients
Number of Sites 62 sites
Follow-up Rate 88%
Safety Findings The sponsor voluntarily recalled this device in June of 2008 due to complaints involving detachment of the tip from the stent delivery System.
Strengths & Weaknesses Strengths: Post approval study aided in uncovering problem with stent delivery. Weaknesses: There was no control group enrolled in this study.
Label Changes Not applicable, stent no longer marketed.

SONOMA Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 10/27/2007 10/29/2007 Overdue/Received
Interim Report 10/27/2008 10/27/2008 On Time
Final Report 03/31/2010 03/05/2010 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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