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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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MAVErIC II Long Term Study


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General
Application Number P070012 / PAS001
Current Plan Approved 10/23/2007
Study Name MAVErIC II Long Term Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of the MAVErIC Phase I and II studies was to demonstrate the safety and efficacy of the Exponent Self-Expanding Carotid Stent System with the GuardWire Plus Temporary Occlusion and Aspiration System for the treatment of carotid stenosis. A Supplement (S059) to the IDE reducing the patient follow-up from the existing 5-year to 3-year follow up for both the MAVErIC Phase I and Phase II Clinical Trials was submitted on June 6, 2006, and approved on June 16, 2006.
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) Patients with 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) Patients having a vessel with reference diameters between 4.5 mm and 9.5 mm at the target lesion.
Sample Size 399 patients
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, myocardial infarction (Q wave and non-Q wave), and ipsilateral stroke. The primary endpoint in the statistical analysis plan 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 Patient follow up occurring at 30 days for all 1500 patients enrolled in the study and 365 days for the first 500 patients enrolled.
Final Study Results
Interim Safety Information Study completed, see final results.
Number of Patients MAVErIC I study: 99 patients; MAVErIC II study: 399 patients
Number of Sites NA
Follow-up Rate 69%
Safety Findings Adjudicated all-cause death rate at 3-years postprocedure was 21.8% (87/399). The total rate of myocardial infarction was 3.8% (15/399). The total rate of stroke was 6.5% (26/399). The rate of target lesion revascularization was 3.5% (14/399).
Strengths & Weaknesses Strengths: The sponsor did enroll and follow-up additional subjects then was originally asked for by FDA.
Weaknesses: Sponsor did not calculate lost to follow-up based on an intention to treat method. If one was to substitute the study sample size of 399 as the denominator the 3-year follow-up would be 69%.
Label Changes Labeling was not updated since the device is no longer marketed.


MAVErIC II Long Term Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month final report 04/23/2008 05/05/2008 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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