A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection

Inclusion Criteria: * Documented stenotic atherosclerotic lesion located at carotid bifurcation and / or proximal internal carotid artery (ICA) * Subject is either (A) symptomatic within 6 months of procedure, with an ipsilateral carotid stenosis ≥ 50% by angiography, or (B) asymptomatic with carotid stenosis ≥ 70% by angiography * Target lesion can be covered by a single stent of no more than 40 mm in length * Target lesion reference vessel diameter (RVD) is 4.0 mm - 7.0mm * Sufficient landing zone required for successful deployment of integrated embolic protection filter * Willing to comply with all follow-up required study visits * Provision of written informed consent before index procedure Exclusion Criteria: * Life expectancy of less than one year * An evolving, acute or recent stroke within 14 days of study evaluation * Acute myocardial infarction within 72 hours before procedure * Known sensitivity to contrast media that cannot be adequately controlled with pre-medication * Subject has a total occlusion of target carotid artery * Subject has a previously place stent in ipsilateral carotid artery * Severe circumferential lesion calcification that may restrict full deployment of carotid stent * Presence of filling defect or thrombus in target vessel * Presence of "string sign" of target vessel * Carotid (intracranial) stenosis located distal to target lesion * Greater than 50% stenosis of common carotid artery proximal to target lesion. * Known mobile plaque in aortic arch