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|
| General |
| Study Status |
Terminated |
Application Number /
Requirement Number |
P070012 / PAS002 |
| Date Original Protocol Accepted |
10/23/2007
|
| Date Current Protocol Accepted |
10/23/2007
|
| Study Name |
EMERGE
|
| Device Name |
EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The primary objective of the EMERGE study is to evaluate the safety of the Exponent Carotid Stent System with distal embolic protection in routine clinical practice for the treatment of carotid stenosis in patients at high risk for carotid endarterectomy and to identify rare or unanticipated device-related events that might occur with use of the devices.
|
| 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) 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) having a vessel with reference diameters between 4.5 mm and 9.5 mm at the target lesion.
|
| Sample Size |
1500 patients, 50 sites
|
| 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, MI (Q wave and non-Q wave), and ipsilateral stroke. The primary endpoint 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 |
All patients will be followed to 30 days, the first 500 patients will be followed for 365 days.
|
| Interim or Final Data Summary |
| Interim Results |
None, no patients were ever enrolled in this study
|
| Actual Number of Patients Enrolled |
0
|
| Actual Number of Sites Enrolled |
0
|
| Patient Follow-up Rate |
Not applicable
|
| Final Safety Findings |
None, study was never started.
|
| Study Strengths & Weaknesses |
None, study was not conducted.
|
| Recommendations for Labeling Changes |
No labeling changes recommended since study was not conducted.
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