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Purpose: The objective of the this study is to provide additional information that the commercially available Abbott Vascular Carotid Stent Systems and Embolic Protection Systems can be used successfully by a wide range of physicians under commercial use conditions. This study will provide an ongoing post-market surveillance mechanism for documentation of clinical outcomes and for possible extension of the Centers for Medicare and Medicaid Services (CMS) coverage to a broader group of patients.
Description: This is a prospective, non-randomized, multicenter, descriptive, post-market study of two FDA approved Embolic Protection Systems sponsored by Abbott Vascular. Patients will be evaluated using the National Institutes of Heath Stroke Scales by a medical professional 14 days prior to the stent procedure, within 24 hours post-procedure and 30 days post-procedure along with normal routine care.
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: Abbott Vascular
Phase: Phase 4
Trial ID: 00403
Not Accepting Healthy Volunteers