Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting

Inclusion criteria

• 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.

Exclusion criteria

• Planned interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index carotid procedure.
• Severe vascular anatomy that would preclude safe sheath insertion, deliverability of stent or embolic protection device.
• Type III or bovine aortic arch.
• Total occlusion of the target vessel.
• Presence of "String sign" of the target lesion.
• In-tandem lesions with >= 50% or >= 80% diameter stenosis for symptomatic or asymptomatic patients, respectively, which cannot be covered by a single CGuard™ stent.
• History of bleeding diatheses or coagulopathy or inability to accept blood transfusions.
• Bilateral carotid stenosis requiring treatment on both sides within 30 days prior to or following planned index procedure.
• Subject is on renal replacement therapy or has Stage 4 or 5 Chronic Kidney Disease (CKD).
• Known reason for potential stroke other than carotid artery stenosis, including history of atrial fibrillation or other sources of thromboemboli within the past 12 months.
• History of thrombophilia.
• Known sensitivity or allergy to nitinol, titanium, heparin, aspirin or other anticoagulant/ antiplatelet therapies.
• Contrast media sensitivity or allergy that cannot be pre-treated.
• Previous stent placement in the target vessel.
• Evolving stroke or intracranial hemorrhage, or history of previous intracranial hemorrhage or brain surgery within the past 12 months.
• Major neurologic deficit with NIHSS of ≥ 15.
• Dementia or other neurologic condition confounding the neurologic assessment.
• Clinical condition that, in the opinion of the investigator, makes endovascular therapy impossible or hazardous.
• Subject previously enrolled in this clinical trial.
• Possible / probable non-compliance of subject with protocol required follow up or medication.
• Subject is currently participating in another clinical trial that has not completed its primary endpoint assessment or would confound this C-GUARDIANS Pivotal IDE Clinical Study.
• SARS-CoV2 (COVID-19) active infection.