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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P050025 / PAS001 |
| Date Original Protocol Accepted |
10/12/2006
|
| Date Current Protocol Accepted |
10/12/2006
|
| Study Name |
CABERNET Registry
|
| Device Name |
ENDOTEX NEXSTENT CAROTID STENT AND DELIVERY SYSTEM AND ENDOTEX CAROTID STENT AND MONORAIL 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 |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
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.
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| Study Population |
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.
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| Sample Size |
488 patients including 454 registry patients and 34 Roll-In patients, 21 sites
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| Key Study Endpoints |
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.
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| Follow-up Visits and Length of Follow-up |
Follow-up at 30 days and one year post procedure
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
488 patients
|
| Actual Number of Sites Enrolled |
21 sites
|
| Patient Follow-up Rate |
86%
|
| Final 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.
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| Study 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.
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| Recommendations for Labeling 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.
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