Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure

Inclusion Criteria

• Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis:
• Symptomatic: Stenosis must be greater than or equal to 50% as determined by angiogram and the patient has a history of stroke (minor or non-disabling), TIA and/or amaurosis fugax within 180 days of the procedure.
• Asymptomatic: Stenosis must be greater than or equal to 70% as determined by angiogram without any neurological symptoms within the prior 180 days.
• Target vessel must meet diameter requirements for stent (refer to selected stent IFU for diameter requirements).
• Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
• Patient is greater or equal to 18 years of age.
• Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure.
• Patient understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Investigational Review Board/Ethics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study.
• Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
• Patient meets at least one of the anatomic or clinical high-risk criteria.

Exclusion Criteria

• Patient has chronic atrial fibrillation.
• Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
• Patient has an evolving stroke.
• Patient has severe dementia.
• Patient has a history of spontaneous intracranial hemorrhage within the past 12 months.
• Patient has had a recent ( 1.5, bleeding time >1 minute beyond upper limit normal, or heparin-associated thrombocytopenia.
• Patient has an intracranial tumor.
• Patient is actively participating in another drug or device trial (IND or IDE) that has not completed the required protocol follow-up period.
• Patient has inability to understand and cooperate with study procedures or provide informed consent.
• Occlusion or [Thrombolysis In Myocardial Infarction Trial (TIMI 0)] "string sign" >1cm of the ipsilateral common or internal carotid artery.
• Patient has vertebrobasilar insufficiency symptoms only, without clearly identifiable symptoms referable to the study carotid artery.
• Knowledge of cardiac sources of emboli.e.g. left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma).
• Recently ( 5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings.
• Patient has had a previous intervention in the ipsilateral proximal CCA.
• Patient has had a TIA or amaurosis fugax within 48 hours prior to the procedure.
• Patient has contralateral lateral recurrent, laryngeal or vagus nerve injury.
• Patient is otherwise unsuitable for intervention in the opinion of the investigator.