Study:
Boston Scientific EPI: A Carotid Stenting Trial for High-Risk Surgical Patients
Rationale:
n/a
Purpose:
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
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Carotid Artery Diseases Stroke Cerebral Arteriosclerosis |
Device: WALLSTENT® Endoprosthesis™ |
N/A |
Verified by
Boston Scientific Corporation
August, 2008
Sponsored by: Boston Scientific Corporation
Information provided by: Boston Scientific Corporation
ClinicalTrials.gov identifier: NCT00316108
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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