• Patient is ≥ 18 years and \< 80 years of age.

• Patient is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.

• Patient is diagnosed with carotid artery disease treatable with a Carotid Artery Stent via a Transcarotid Artery Revascularization approach and is either symptomatic or asymptomatic, defined as:

• Symptomatic carotid stenosis ≥ 50%. Symptomatic is defined as amaurosis fugax, transient ischemia attack (TIA) or stroke within the last 6 months ipsilateral to the side of the stenosis Or

• Asymptomatic carotid stenosis ≥ 80%

• High Risk condition for CEA: at least one, as shown below:

⁃ Comorbid conditions:

• Age ≥ 70 (maximum 80 years)

• CCS angina class 3-4 or unstable angina

• Congestive Heart Failure (CHF) NYHA class III-IV

• Left ventricular ejection fraction (LVEF) ≤ 35%

• MI ≥ 72 hours and \< 6 weeks pre-procedure

• Multi-vessel CAD (≥ 2 vessels \>70% stenosis) and history of angina

• Chronic Obstructive Pulmonary Disease (COPD) with FEV1\<50

• Permanent contralateral cranial nerve injury/paralysis

• Restenosis from previous carotid endarterectomy (CEA)

• Planned coronary artery bypass grafting (CABG) or valve replacement surgery between 31-60 days after CAS

• Abdominal aortic aneurysm surgical repair or Endovascular repair is planned between 31 to 60 days after CAS.

⁃ Anatomic conditions:

• Occlusion of the contralateral CCA or ICA.

• Prior radiation treatment to the neck or a radical neck dissection.

• Severe bilateral ICA stenosis requiring treatment.

• Target lesion at or above the level of the jaw (C2) or below the clavicle.

• Severe tandem lesions

• Inability to extend the neck due to cervical disorders.

• Laryngeal palsy or laryngectomy.

• Prior head and neck surgery in the region of the carotid artery.

• Tracheostomy or tracheostoma.

• Spinal immobility of the neck.

• Hostile neck or surgically inaccessible lesion.

• Target vessel and lesion meet all requirements for the CGuard Prime™ 80 stent:

• Target lesion location at the carotid bifurcation and/or proximal internal carotid artery (ICA)

• The diameter at the stent landing zone is between 4.8 mm and 9.0 mm.

• The target lesion length is ≤ 36 mm and can be covered by a single CGuard Prime™ 80 stent.

• Patient must have a 5 cm long disease-free segment of the common carotid artery (CCA) measured from the clavicle to the carotid bifurcation, with a minimum vessel diameter of 6 mm suitable for vascular access, sheath insertion, and vessel clamping.