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

Inclusion 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. Targeted vessel diameter for FiberNet placement between 1.75 mm and 7.0 mm. The investigator determines that all branch vessels distal to the target lesion and proximal to the proposed site of device deployment will be adequately protected. Exclusion Criteria: Prior stenting of ipsilateral carotid. Planned treatment of contralateral carotid within 30 days. Experienced a myocardial infarction within the last 14 days. Undergone an angioplasty or PTCA/PTA procedure within the past 48 hours. Undergone cardiac surgery within the past 60 days. Has a planned invasive surgical procedure within 30 days. Suffered a stroke within the past 14 days. Suffered a transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours. Total occlusion of the target vessel. Lesions within 2 cm of the ostium of the common carotid artery. A stenosis that is known to be unsuitable for stenting because of one or more of: Tortuous or calcified anatomy proximal or distal to the stenosis, Presence of visual thrombus, Pseudo occlusion (string sign). Serial lesions that requires more then one stent to cover entire lesion.