Multicenter evaluation of a self-expanding carotid stent system with distal protection in the treatment of carotid stenosis

Michael D. Hill, W. Morrish, G. Soulez, A. Nevelsteen, G. Maleux, C. Rogers, K. E. Hauptmann, A. Bonafé, R. Beyar, L. Gruberg, J. Schofer

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)759-765
Number of pages7
JournalAmerican Journal of Neuroradiology
Volume27
Issue number4
StatePublished - Apr 2006
Externally publishedYes

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Carotid Stenosis
Stents
Stroke
Carotid Endarterectomy
Myocardial Infarction
Therapeutics
Carotid Artery Diseases
National Institutes of Health (U.S.)
Carotid Arteries
Angiography
Pathologic Constriction
Safety
Mortality
Population
milbemycin oxime

ASJC Scopus subject areas

  • Clinical Neurology
  • Radiology Nuclear Medicine and imaging
  • Radiological and Ultrasound Technology

Cite this

Hill, M. D., Morrish, W., Soulez, G., Nevelsteen, A., Maleux, G., Rogers, C., ... Schofer, J. (2006). Multicenter evaluation of a self-expanding carotid stent system with distal protection in the treatment of carotid stenosis. American Journal of Neuroradiology, 27(4), 759-765.

Multicenter evaluation of a self-expanding carotid stent system with distal protection in the treatment of carotid stenosis. / Hill, Michael D.; Morrish, W.; Soulez, G.; Nevelsteen, A.; Maleux, G.; Rogers, C.; Hauptmann, K. E.; Bonafé, A.; Beyar, R.; Gruberg, L.; Schofer, J.

In: American Journal of Neuroradiology, Vol. 27, No. 4, 04.2006, p. 759-765.

Research output: Contribution to journalArticle

Hill, MD, Morrish, W, Soulez, G, Nevelsteen, A, Maleux, G, Rogers, C, Hauptmann, KE, Bonafé, A, Beyar, R, Gruberg, L & Schofer, J 2006, 'Multicenter evaluation of a self-expanding carotid stent system with distal protection in the treatment of carotid stenosis', American Journal of Neuroradiology, vol. 27, no. 4, pp. 759-765.
Hill, Michael D. ; Morrish, W. ; Soulez, G. ; Nevelsteen, A. ; Maleux, G. ; Rogers, C. ; Hauptmann, K. E. ; Bonafé, A. ; Beyar, R. ; Gruberg, L. ; Schofer, J. / Multicenter evaluation of a self-expanding carotid stent system with distal protection in the treatment of carotid stenosis. In: American Journal of Neuroradiology. 2006 ; Vol. 27, No. 4. pp. 759-765.
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abstract = "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.",
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AU - Hill, Michael 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.

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N2 - 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.

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