A Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When Used in Conjunction to the ENROUTE Transcarotid Neuroprotection System in Patients Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization Approach

Exclusion Criteria

• •Patient had or will have an interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index carotid procedure.
• •Patient had or will have open heart surgery or valvular intervention (percutaneous or surgical), or any major operation, within 30 days before or after the index carotid procedure.
• •Vascular anatomy that would preclude safe sheath insertion or deliverability of stent
• •Patient had a previously placed stent in the ipsilateral ICA or CCA.
• •Total occlusion or presence of a "string sign" of the ipsilateral ICA or CCA.
• •Presence of a filling defect of the target lesion.
• •Tandem lesions, which cannot be covered by a single CGuard Prime™ stent.
• •Patient has a stenosis of the innominate artery or proximal CCA requiring revascularization
• •Patient has an open neck stoma.
• •Patient has a history of bleeding diatheses or coagulopathy.
• •Patient has hypercoagulable state.
• •Patient has an alternative source of cerebral embolus, including but not limited to:
• •1. Chronic atrial fibrillation.
• •2. Episode(s) of paroxysmal atrial fibrillation within the past 6 months or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
• •3. Knowledge of cardiac sources of embolus (e.g. left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma).
• •4. Recently (\<60 days) implanted heart valve (either surgically or endovascularly) as a known source of emboli as confirmed on echocardiogram,
• •5. Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis (as determined by angiography or CTA/MRA 6 months prior to index procedure) greater in severity than the lesion to be treated; cerebral aneurysm \> 5mm; AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings.
• •Patient has a known sensitivity or allergy to nickel or titanium.
• •Patient has a sensitivity to contrast media that cannot be adequately pre-treated.
• •Patient has a sensitivity to both forms of protocol-acceptable anticoagulation strategies (i.e., both heparin AND Bivalirudin)
• •Patient has a sensitivity to an antiplatelet agent AND all protocol acceptable alternative antiplatelet options
• •Patient has a known intolerance to statins.
• •Patient has a life expectancy of less than 3 years from the date of enrollment as determined by the Wallaert Life Expectancy Scale
• •Patient has malignancy, primary or recurrent, and does not have independent assessment of life expectancy performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.
• •Patient has an evolving stroke or intracranial hemorrhage, or a history of previous intracranial hemorrhage or brain surgery within the past 12 months.
• •Patient had a recent stroke (≤ 7 days) placing him/her at risk of a hemorrhagic conversion during the index procedure.
• •Patient has a history of a major stroke with a neurologic deficit (NIHSS of ≥ 15 or mRS ≥3).
• •Patient had a TIA or amaurosis fugax or stroke within 48 hours of the index procedure.
• •Female patient who is pregnant or lactating or is planning to become pregnant.
• •Dementia or other neurologic condition that is likely to confound the neurologic assessment.
• •Clinical condition that, in the opinion of the investigator, makes endovascular therapy impossible or hazardous.
• •Patient has been previously enrolled in this clinical trial.
• •Patient is likely to be non-compliant with protocol-required follow up or medication in the opinion of the investigator.
• •Patient is currently participating in another clinical trial that has not completed its primary endpoint assessment or that may confound this study results.