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Boston Scientific Embolic Protection, Inc. (EPI): A Carotid Stenting Trial for High-Risk Surgical Patients (BEACH)


Boston Scientific EPI: A Carotid Stenting Trial for High-Risk Surgical Patients




The purpose of this study is to determine whether morbidity and mortality for high-risk surgical patients treated with the Carotid Wallstent in conjunction with the FilterWire EX and EZ System distal protection device will be less than or equal to that of objective performance criteria (OPC) derived from historic controls undergoing surgical intervention with a carotid endarterectomy (CEA).

Study Status: Completed


Condition Intervention Phase
Carotid Artery Diseases
Cerebral Arteriosclerosis
Device: WALLSTENT® Endoprosthesis™ N/A

Verified by Boston Scientific Corporation July, 2012

Sponsored by: Boston Scientific Corporation
Information provided by: Boston Scientific Corporation identifier: NCT00316108

Study Type: Interventional

Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic & Foundation
Cleveland, Ohio 44195
United States

Christopher White, MD., Principal Investigator
Sriram Iyer, MD., Principal Investigator
Pamela G Grady, Ph.D., Study Director

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