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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P070012 / PAS001 |
| Date Original Protocol Accepted |
10/23/2007
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| Date Current Protocol Accepted |
10/23/2007
|
| Study Name |
MAVErIC II Long Term Study
|
| Device Name |
EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Concurrent Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
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.
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| Study Population |
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.
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| Sample Size |
399 patients
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| Key Study Endpoints |
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.
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| 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.
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| Interim or Final Data Summary |
| Interim Results |
Study completed, see final results.
|
| Actual Number of Patients Enrolled |
MAVErIC I study: 99 patients; MAVErIC II study: 399 patients
|
| Actual Number of Sites Enrolled |
NA
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| Patient Follow-up Rate |
69%
|
| Final 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).
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| Study 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%.
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| Recommendations for Labeling Changes |
Labeling was not updated since the device is no longer marketed.
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