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 Stroke Amaurosis Fugax Transient Ischemic Attack (TIA) Subject must be ≥ 18 years of age. 2. Subject does not have any condition that limits their anticipated survival to less than 3 years. 3. Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure. 4. Subjects with neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram OR- 5. Subjects without neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram. 6. Subject with all the following target vessel characteristics: 1. Discrete lesion in internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA). 2. Vessel diameter ≥ 4.0 mm and ≤ 9.0 mm from reference or contralateral artery. 3. Absence of excessive vessel tortuosity that would impede delivery of devices. 7. Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure  Subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (CEA). 2. Subject with Hgb <10.g/dl or platelet count < 125,000 µl or has heparin-associated thrombocytopenia. For subjects on Coumadin (Warfarin) and for subjects with a platelet or coagulation disorder: Has an international normalized ratio (INR) > 1.5. 3. Subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions. 4. Subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such. 5. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. 6. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test