Multicenter Evaluation of a Self-Expanding Carotid Stent System with Distal Protection in the Treatment of Carotid Stenosis

• Published in: American Journal of Neuroradiology Vol. 27; no. 4; pp. 759 - 765
• Main Authors: Hill, M.D, Morrish, W, Soulez, G, Nevelsteen, A, Maleux, G, Rogers, C, Hauptmann, K.E, Bonafe, A, Beyar, R, Gruberg, L, Schofer, J, MAVErIC International Investigators
• Format: Journal Article
• Language: English
• Published: Oak Brook, IL Am Soc Neuroradiology 01-04-2006; American Society of Neuroradiology
• Subjects: Aged; Biological and medical sciences; Carotid Stenosis - surgery; Electrocardiography. Vectocardiography; Electrodiagnosis. Electric activity recording; Embolism - prevention & control; Equipment Design; Eye; Feasibility Studies; Female; Filtration - instrumentation; Follow-Up Studies; Humans; Interventional; Investigative techniques, diagnostic techniques (general aspects); Male; Medical sciences; Nervous system; Radiodiagnosis. Nmr imagery. Nmr spectrometry; Radionuclide investigations; Stents - adverse effects; Nervous system diseases; Treatment; Radiodiagnosis; Self evaluation; Blood vessel; Carotid; Stenosis; Circulatory system; Protection; Stent; Artery
• ISSN: 0195-6108; 1936-959X; 1432-1920

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.
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.
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.
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.