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Protected Carotid Stenting in High-Risk Patients: Results of the SpideRX Arm of the Carotid Revascularization with ev3 Arterial Technology Evolution Trial JOURNAL OF INTERVENTIONAL CARDIOLOGY Safian, R. D., Jaff, M. R., Bresnahan, J. F., Foster, M., Bacharach, J., Yadav, J., Joye, J., Myla, S., Kassab, E., Mann, J., Ansel, G. M., CREATE SpideRX Trial Investigators 2010; 23 (5): 491–98

Abstract

A prospective nonrandomized multicenter registry of 160 patients with severe carotid stenosis and high-risk features for carotid endarterectomy was conducted during the 3-month period from March to May 2005.Carotid artery stenting (CAS) was performed with the SpideRX™ Embolic Protection System (ev3, Inc., Plymouth, MN, USA) as part of an investigational device exemption from the Food and Drug Administration.The primary end-point of major adverse cardiac and cerebrovascular events at 30 days after CAS was observed in nine patients (5.6%), including death in four patients (2.5%), nonfatal stroke in five patients (3.1%), and nonfatal myocardial infarction in one patient (0.6%). A secondary end-point of technical success (defined as successful deployment of all devices, filter retrieval, and final diameter stenosis <50%) was achieved in 156 of 160 patients (97.5%). The only independent predictor of death or stroke at 30 days was baseline stenosis severity (P < 0.05).CAS with distal embolic protection using the SpideRX™ Embolic Protection System is a reasonable alternative for revascularization of some high-risk patients with severe carotid stenosis.

View details for DOI 10.1111/j.1540-8183.2010.00578.x

View details for Web of Science ID 000282513700011

View details for PubMedID 20624206