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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Study Status Completed
Application Number P050019 / PAS001
Date Current Protocol Accepted 10/23/2008
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Concurrent & Historical Control
Analysis Type Analytical
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The CABANA study is a multi-center surveillance registry. The objectives of the registry are to:

1) to compile early clinical outcomes data for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice, 2) to evaluate clinical outcomes using the death, stroke, and myocardial infarction rate at 30 days or less, in total and by center experience tier, and 3) to assess the adequacy of the Boston Scientific Corporation Carotid Stenting Training Program.
Study Population Description The Carotid WALLSTENT Monorail Endoprosthesis, used in conjunction with the Boston Scientific embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy due to either anatomic or co-morbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease. This includes patients with neurological symptoms and > 50% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram, or patients without neurological symptoms and > 80% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram and patients with a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.
Sample Size 1,500 patients, 150 sites
Data Collection The endpoint for the 1,000 newly enrolled patients will be a 30-day composite death, stroke and myocardial infarction
Follow-up Visits and Length of Follow-up Patients will be followed at 30 days and annually through 3 years.
Interim or Final Data Summary
Interim Safety Information The 30 day myocardial infarction rate in the BEACH trial was 1.0% while it is 0.5% in the CABANA trial. Death (0.7% in CABANA vs. 1.5% in BEACH) and stroke rates (2.5% in CABANA vs. 4.2% in BEACH) are lower in the CABANA trial than they were in the BEACH pre-market study. The rates of center-reported serious adverse events and non-serious adverse events were 20.1 % (111/553 subjects) and 32.7% (181/553 subjects), respectively. No serious, device-related events that were unanticipated have occurred.
Actual Number of Patients Enrolled 1097
Actual Number of Sites Enrolled 99
Patient Follow-up Rate 95%
Final Safety Findings Of the 1,025 subjects evaluable for 30-day postprocedure MAE, 0.5% (5/1,025) had MIs, 3.3% (34/1,025) had strokes, and 1.3% (13/1,025) had CEC-adjudicated deaths, contributing to an overall CEC-adjudicated MAE rate of 4.6% (47/1,025). Out of the 34 subjects who had strokes within 30 days postprocedure, the majority (58.8%; 20/34) had strokes that were classified as ¿major,¿ while the rest (41.2%; 14/34 ) had strokes classified as ¿minor.¿ In almost all of the 34 subjects with stroke, the stroke was on the ipsilateral side (88.2%; 30/34) and in most cases the stroke was considered ischemic (85.3%; 29/34).
Final Effect Findings The sponsor reports that system technical success was achieved in 97.1% of evaluable subjects.
Study Strengths & Weaknesses The sponsor reports good follow-up of study subjects. However, the study may not have been adequately powered to detect rare adverse events.
Recommendations for Labeling Changes Yes


Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 04/23/2009 04/22/2009 On Time
1 year report 10/23/2009 10/23/2009 On Time
18 month report 04/23/2010 04/20/2010 On Time
2 year report 10/23/2010 10/20/2010 On Time
final report 03/23/2011 03/23/2011 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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