| Trial Design: | A prospective, non-randomized, multi-center registry. N=454. (Symptomatic 50% stenosis by Doppler ultrasound and angiogram;asymptomatic 80% stenosis by Doppler ultrasound or 60% stenosis as determined by angiogram without any neurological symptoms.) 21 sites participated in the study. At 2 sites the study was transitioned to other institutions. Of the remaining 19 sites, there were 15 US sites and 4 OUS sites. |
| Trial Objective: | To evaluate the safety and efficacy of the NexStent® Carotid Stent and Delivery System and the Boston Scientific FilterWire EX® and FilterWire EZ™ Embolic Protection Systems by assessing the outcomes of patients with carotid artery stenosis in the ICA, CCA or ICA/CCA bifurcation who are at high risk for carotid endarterectomy (CEA). |
| 30-Day Major Adverse Event Rates (N=439): | Pivotal Group: 3.9% • Death: 0.5% • Stroke: 3.4% • MI: 0.2% |
| 30-Day All Stroke Rate (N=439): | All Stroke 3.4% Minor: 2.1% Major: 1.3%
Ipsilateral Stroke 2.7%
Non-Ipsilateral Stroke 0.7% |
| Primary Endpoint #1: | A composite major adverse event rate including: 0-30 days: all Death, Stroke and MI (Q and non-Q-wave),plus Ipsilateral Stroke, including any death related to ipsilateral stroke, from 31-365 days (1 year). |
| 1-Year Major Adverse Event Rates (N=404): | Pivotal Group: 4.7%* • Death: 0.5% • Stroke: 4.2% • MI: 0.2% *Patients may have had more than one event. |
| Primary Endpoint #2: | 0-365 days (1 year): all Death, all Stroke, all MI (Q and non-Q-wave). Note: All D/S/MI means any death, stroke or MI that is related or NOT related to the target treated lesion/vessel. For example, if a patient died of cancer, their death was included in the final calculation. |
| 1-Year Major Adverse Event Rates (N=421): | Pivotal Group: 11.9%** • Death: 4.5%† • Stroke: 5.0% • MI: 4.0% **11 patients experienced multiple events. |
