A Multicenter, Single-Arm, Pivotal Study to Evaluate the Safety and Efficacy of the CGuard™ Carotid Stent System When Used to Treat Symptomatic and Asymptomatic Carotid Artery Stenosis in Patients Undergoing Carotid Artery Stenting

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

• Subject is willing and able to take dual antiplatelet therapy for a minimum of 30 days.

• Life expectancy ≥ 24 months from the date of the index procedure.

• Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.

• Subject has a modified Rankin Score of ≤ 2at the time of informed consent.

• Subject is diagnosed with carotid artery disease treatable with carotid artery stenting and is considered high risk for carotid endarterectomy (CEA) as evidenced by:

∙ 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%

• Co-Morbidity High Risk Conditions for CEA, i.e., meets one or more of the following criteria:

∙ 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 repair or peripheral vascular surgery is planned between 31 to 60 days after CAS.

• OR

• High Anatomical Risk for CEA, i.e., meets one or more of the following criteria:

∙ 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 hear 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.

⁃ Angiographic General Inclusion Criteria, i.e., meets all the following criteria:

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

• Vessel distal to target lesion can accommodate a distal embolic protection device (EPD), and EPD is compatible with CGuard™ device (refer to CGuard™ System IFU for specific EPDs).

• Target vessel reference diameter at stent landing zone is 4.8 mm to 9.0 mm.

• Target lesion length ≤ 36 mm, that can be covered by a single CGuard™ stent.