Patient description: A 46-year-old man presents with dizziness and frequent headaches. He has a family history of CAD, but no other cardiovascular risk factors such as smoking, high blood pressure, and diabetes mellitus and is physically active. The patient's LDL-C and HDL-C levels were 545 and 53 mg/dL, respectively. His fasting glucose and triglyceride levels (85 and 158 mg/dL, resp.) were within normal limits. The patient reported no use of lipid-lowering medications. Neck auscultation revealed a systolic murmur 3+/6+ in the neck, radiating to the skull. Ultrasonography of the carotid arteries, revealed severe stenosis in the left internal carotid artery (LICA), as well as moderate stenosis in the right internal carotid artery (RICA) estimated between 40% and 50%. For the LICA, the peak-systolic (PSV) and end-diastolic velocity (EDV) cutoff values were 208.5 cm/s and 54.5 cm/s, respectively; RICA PSV was 91.72 cm/s and RICA EDV was 37.37 cm/s. Plaque was observed in the anterior and posterior walls of the internal carotid artery and common carotid artery, which were characterized as bulky plates extending to the middle third of the internal coronary arteries (ICAs) and as predominantly echogenic and hyperechoic, with less than 50% of the area being echolucent with uneven surfaces.

Clinical trial eligibility criteria: eligible ages (years): 18.0-999.0,  Carotid Artery Disease General Subject meets one or more of the high surgical risk criteria Subject is ≥ 18 years old Subject is a candidate for single lesion carotid artery stenting using a femoral arterial approach Subject is willing and able to comply with follow-up evaluations at the specified times Subject (or legal representative) understands the nature of the procedure and provides informed consent, prior to enrollment in the study If female subject, is not currently pregnant and has stated that she has no intention of becoming pregnant during the study. Angiographic (as determined ≤ 30 days prior to procedure) Target lesion stenosis (% stenosis = (1-N/D) X 100)1, documented by selective angiography pre-intervention, is ≥ 80% stenosis for asymptomatic subjects or ≥ 50% stenosis for symptomatic subjects. Symptomatic is defined as carotid stenosis associated with ipsilateral transient or visual TIA evidenced byamaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral ischemic stroke within 6 months prior to enrollment Target lesion is within the internal carotid artery and/or involves the bifurcation of the CCA  Subject has participated in, is participating in, or plans to participate in another clinical study that may affect either the pre-procedure or follow-up results Subject has chronic or paroxysmal atrial fibrillation that is not treated by Coumadin Subject has undergone prior stenting of the ipsilateral carotid artery Subject's life expectancy is less than twelve months Subject is unable to respond to external questions and stimuli and to exert a pressure with the contralateral hand Subject is suffering from dementia Subject has documented intolerance to BOTH heparin and Angiomax Subject has an allergy or contraindication to acetylsalicylic acid (ASA) Subject has a documented allergy to the device materials Subject has a documented allergy to radiographic contrast that cannot be pre-treated