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

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