The study is a prospective, non-randomized, single-arm, multi-center registry to confirm the safe delivery of the Carotid WALLSTENT Endoprosthesis when used with the ENROUTE® Transcarotid Neuroprotection System in the Chinese population
1. Patients must meet one of the following criteria regarding neurological symptom status and degree of stenosis: Symptomatic: Stenosis must be >50% as determined by an angiogram (CTA/MRA or catheter angiogram prior to the index procedure) and the patient has a history of stroke (minor or non-disabling; NIHSS ≤4 or mRS ≤2), TIA and/or amaurosis fugax within 180 days of the procedure ipsilateral to the carotid artery to be stented.
Patient has chronic atrial fibrillation.
Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
Knowledge of any cardiac sources of emboli. (including but not limited to 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).
Recently (<60 days) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram.
Subjects will come from patients in each sites.
Cohort
Prospective
transcarotid artery revascularization
DeviceThe ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis and who have appropriate anatomy described below: * Adequate femoral venous access * Common carotid artery reference diameter of at least 6 mm * Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex ultrasound (DUS) or computerized axial tomography (CT) angiography or magnetic resonance (MR) angiography.
• Procedural success
technical success in the absence of a Major Adverse Event
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