Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™ "CABERNET"

Completed

Phase 3 Results

Results

In patients enrolled in the study, the 30-day composite major adverse event (MAE) rate, defined as all-cause stroke, death and myocardial infarction (MI) -- was 3.8 percent. This corresponds to a per-patient breakdown of MAE events to include: death, 0.5 percent; stroke, 3.4 percent; and MI, 0.2 percent, and compares favorably to other high-risk carotid artery stenting trials. The NexStent device success, defined as successful delivery and placement of the stent at the intended target site was 96.9 percent. The device success for the FilterWire EX and EZ, defined as FilterWire successfully placed within the target vessel, was 99.1 percent. Both reported device success rates correspond to a per-patient assessment.