The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS Study)

Inclusion Criteria: * Subject must be \> 21 years of age. * Subject has the ability to understand and cooperate with study procedures and agrees to return for all required follow-up visits, tests, and exams. * International Normalized Ratio (INR) must be ≤ 1.5 at the time of the procedure (subjects taking warfarin may be included if their dose is tapered prior to the procedure to meet the inclusion criterion. Dose may be returned to a therapeutic level after the procedure). * The subject must sign a written informed consent prior to the procedure, using a form that is approved by the local medical Ethics Committee (EC). * The life expectancy of the subject is at least one year. * The subject has a lesion located in the internal carotid artery (ICA); the carotid bifurcation may be involved. * The subject must have a minimum distance of 5 cm between the clavicle and bifurcation, as assessed by duplex Doppler ultrasound, computed axial tomographic (CT) angiography or magnetic resonance (MR) angiography. Exclusion Criteria: * The subject is participating in another investigational study that would interfere with the conduct or result of this study. * The subject has dementia or a neurological illness that may confound the neurological evaluation. * Presence of any one of the following anatomic risk factors: * Previous radiation treatment to the neck or radical neck dissection * Tracheostomy or tracheal stoma * Laryngectomy * Contralateral laryngeal nerve palsy * Severe tandem lesions * Inability to extend the head due to cervical arthritis or other cervical disorders * Total occlusion of the target vessel. * There is an existing, previously placed stent in the target artery. * The subject has a known life-threatening allergy to the contrast media that cannot be treated. * Subject has history of intolerance or allergic reaction to any of the study medications including aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), prasugrel heparin or bivalirudin (Angiomax™). Subjects must be able to tolerate a combination of aspirin and clopidogrel/ticlopidine or prasugrel. * The subject has a gastrointestinal bleed that would interfere with antiplatelet therapy. * The subject has known cardiac sources of emboli. * Subject has Hemoglobin (Hgb) less than 8 gm/dL (unless on dialysis), platelet count \< 50,000/mm3, or known heparin associated thrombocytopenia. * Subject has documented atrial fibrillation in the prior 90 days. * The subject has a history of bleeding diathesis or coagulopathy including thrombocytopenia or an inability to receive heparin in amounts sufficient to maintain an activated clotting time (ACT) at \> 250, or if the subject will refuse blood transfusions. * The subject has atherosclerotic disease involving the ipsilateral common carotid artery (CCA) that precludes safe placement of the sheath. * The subject has abnormal angiographic findings other than that of the target lesion that indicate the subject is at risk for a stroke, such as: ipsilateral arterial stenosis greater in severity than the target lesion, cerebral aneurysm, or arteriovenous malformation of the cerebral vasculature. * There is evidence of a carotid artery dissection prior to the initiation of the procedure. * There is an angiographically visible thrombus. * There is any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe, e.g. morbid obesity, sustained systolic blood pressure \> 180 mm Hg, tortuosity, occlusive disease, vessel anatomy or aortic arch anatomy. * Occlusion (TIMI 0 flow), or string sign of the ipsilateral common or internal carotid artery. * There is evidence of bilateral carotid stenosis that would require intervention within 30 days of procedure. * There is evidence of a major stroke (NIHSS ≥10) within the previous 30 days of the procedure or the patient is considered, by the investigator, to be at high risk for hemorrhagic stroke. * There is a planned treatment of a non-target lesion within 30 days post procedure. * There is a history of intracranial hemorrhage within the previous 3 months, including hemorrhagic transformation of an ischemic stroke. * There is history of an ipsilateral stroke with fluctuating neurologic symptoms within one year prior to the procedure. * Female subjects who are pregnant (negative pregnancy test is required in women of childbearing potential). * Subjects, who the Investigator determines, to be at risk of Deep Vein Thrombosis (DVT)