Multicenter experience with a new "hybrid" carotid stent

Purpose: To report the results from a prospective multicenter registry evaluating the safety and performance of a new hybrid stent specifically engineered for carotid indications. Methods: Between October 18, 2006, and March 28, 2007, 124 patients (88 men; mean age 71.8 +/- 7.3 years, range 52-87) underwent Cristallo Ideale stent implantation at 4 expert sites in Italy and Germany. Eligibility criteria included >60% symptomatic and >80% asymptomatic carotid stenosis. Different cerebral protection devices were utilized (proximal protection and distal filters). The primary endpoint was the rate of 30-day major adverse neurological events, defined as major and minor stroke and neurological death by independent neurological assessment. All adverse events were adjudicated by an independent clinical event committee. Results: Stent deployment was completed successfully in all the cases without documented technical failure. There were no neurological events during the procedures. Thirty-day follow-up was available for 119 (96.0%) patients [2 (1.6%) were lost to follow-up and 3 (2.4%) died from non-neurological causes unrelated to the device or procedure]. There were no major adverse neurological events within 30 days, but 2 (1.6%) device-/procedure-related transient ischemic attacks were reported (both resolved completely in <24 hours). Four (3.2%) other non-neurological events (anemia requiring transfusion, worsening of pre-existing chronic renal failure, acute access site thrombosis, and monocular vision disturbance) were reported in the study period. Conclusion: The Cristallo Ideale carotid stent is safe and effective in the periprocedural period. Its newly designed hybrid structure seems to support the rationale of combining adequate plaque scaffolding with high vessel adaptability.