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|
| General |
| Study Status |
Other |
Application Number /
Requirement Number |
P050025 / PAS002 |
| Date Original Protocol Accepted |
10/12/2006
|
| Date Current Protocol Accepted |
10/12/2006
|
| Study Name |
SONOMA
|
| Device Name |
ENDOTEX NEXSTENT CAROTID STENT AND DELIVERY SYSTEM AND ENDOTEX CAROTID STENT AND MONORAIL DELIVERY SYSTEM
|
| 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 Objectives |
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 |
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
|
| Key Study Endpoints |
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.
|
| Interim or Final Data Summary |
| Interim Results |
See final results
|
| Actual Number of Patients Enrolled |
298 patients
|
| Actual Number of Sites Enrolled |
62 sites
|
| Patient Follow-up Rate |
88%
|
| Final 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.
|
| Study Strengths & Weaknesses |
Strengths: Post approval study aided in uncovering problem with stent delivery. Weaknesses: There was no control group enrolled in this study.
|
| Recommendations for Labeling Changes |
Not applicable, stent no longer marketed.
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