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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P050019 / PAS001 |
| Date Original Protocol Accepted |
10/23/2008
|
| Date Current Protocol Accepted |
10/23/2008
|
| Study Name |
CABANA REGISTRY
|
| Device Name |
CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS
|
| 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 Objectives |
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 |
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
|
| Key Study Endpoints |
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.
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| Interim or Final Data Summary |
| Interim Results |
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.
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| 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
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