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Purpose: The primary objective of this study is to assess 30-day outcomes of stenting (any death, stroke or MI) with distal protection in the treatment of obstructive carotid artery disease in high-surgical risk patients with atherosclerotic disease of the carotid artery (ies).
Description: The devices to be utilized are the Cordis PRECISE® Nitinol Stent Systems and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewires (ECGW). These devices are approved for commercial use by the Food and Drug Administration (FDA), thus this study is a prospective observational study. Patients will be seen 30 days and phoned 1 year after their index procedure. They will also be followed by Neurology throughout enrollment for stroke status.
Patients who are high-surgical risk patients with atherosclerotic disease of the carotid artery (ies). High surgical risk patients may include, but are not limited to, Congestive Heart Failure, severe pulmonary disease, post radiation treatment, laryngeal palsy, previous carotid Endarterectomy restenosis or³80 years old. Symptomatic patients having cerebrovascular symptoms (TIA, amaurosis fugax, minor or non-disabling stroke) or asymptomatic patients may be eligible.
Sponsor: Cordis Corporation
Phase: Phase 4
Trial ID: 00369
Not Accepting Healthy Volunteers