EPIC US Feasibility Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting

Inclusion Criteria: * One or more of the high surgical risk criteria. * Candidate for percutaneous stenting with target lesion located within common or internal carotid artery. * Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria. Exclusion Criteria: * Allergy to Heparin. * Myocardial infarction within the last 14 days. * Angioplasty or PTCA/PTA procedure within the past 48 hours. * Cardiac surgery within the past 60 days. * Planned invasive surgical procedure within 30 days. * Stroke within the past 14 days. * Transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours. * Intracranial stenosis that exceeded the severity of an extracranial stenosis. * Peripheral vascular disease of sufficient severity to prevent vascular access to the target lesion. * Total occlusion of the target vessel. * Lesion within 2cm of the ostium of the common carotid artery. * A stenosis that is known to be unsuitable for stenting because of one or more of: 1. Tortuous or calcified anatomy proximal or distal to the stenosis 2. Presence of visual thrombus 3. Pseudo occlusion ('string sign') * Serial lesions that requires more then one stent to cover entire lesion. * Procedural complication prior to introduction of the FiberNet device into the body.