PT  - JOURNAL ARTICLE
AU  - Hill, M.D.
AU  - Morrish, W.
AU  - Soulez, G.
AU  - Nevelsteen, A.
AU  - Maleux, G.
AU  - Rogers, C.
AU  - Hauptmann, K.E.
AU  - Bonafé, A.
AU  - Beyar, R.
AU  - Gruberg, L.
AU  - Schofer, J.
ED - for the MAVErIC International Investigators
TI  - Multicenter Evaluation of a Self-Expanding Carotid Stent System with Distal Protection in the Treatment of Carotid Stenosis
DP  - 2006 Apr 01
TA  - American Journal of Neuroradiology
PG  - 759--765
VI  - 27
IP  - 4
4099  - http://www.ajnr.org/content/27/4/759.short
4100  - http://www.ajnr.org/content/27/4/759.full
SO  - Am. J. Neuroradiol.2006 Apr 01; 27
AB  - PURPOSE: Carotid artery stent placement may be limited by the embolization of atheromatous material. We evaluated the safety and feasibility of the Medtronic Self-Expanding Carotid Stent (Exponent) in combination with the Medtronic Interceptor Carotid Filter System for the treatment of carotid stenosis among patients at high risk for carotid endarterectomy.METHODS: Patients at high risk for carotid endarterectomy but amenable to percutaneous treatment with stent placement were enrolled. Clinical follow-up was performed at 30 days and 6 and 12 months postprocedure. The National Institutes of Health Stroke Scale was assessed before and within 3 days postprocedure and at 30 days and 6 months postprocedure. Angiography was performed pre- and postprocedure, and carotid duplex scans were performed at baseline and at 30 days and 6 months.RESULTS: Fifty-two carotid procedures were performed in 51 patients (mean age, 69 years; 84% of patients were men). The major adverse event (MAE) rate (death, stroke, and myocardial infarction [MI]) at 30 days was 5.9%: 2 strokes and a single death from periprocedural MI. MAE rates after 6 and 12 months were 5.9% and 11.8%, respectively. The delivery success rate was 94.2% (49/52) for the Interceptor Filter System and 95.9% (47/49) for the Exponent Stent. The mean diameter stenosis of the target lesion was reduced from 62.4% preprocedure to 21.2% postprocedure.CONCLUSION: High delivery success rates were achieved with a low rate of MAE (death, stroke, or MI) in a high-risk population. Treatment of carotid artery disease with the Exponent Carotid Stent combined with distal protection from the Interceptor Filter System is effective and safe.