Stent Placement Clinical Trials

• Age ≥ 18 years, male or female;

• Pre-procedural carotid duplex ultrasound and/or computed tomography angiography confirmed stenosis of the common carotid artery, internal carotid artery, or carotid bifurcation, and are considered suitable for endovascular treatment;

• Intra-procedural digital subtraction angiography, using NASCET criteria, confirmed stenosis of ≥ 50% (symptomatic) or ≥ 80% (asymptomatic), and symptomatic is defined as the occurrence of one or more clinical events within 6 months prior to the procedure, including transient ischemic attack, amaurosis fugax, or minor/non-disabling stroke attributable to the ipsilateral intracranial circulation;

• The vessel diameter of the target lesion is between 3.0 mm and 9.0 mm;

• Voluntary participation in this trial and provision of written informed consent.

⁃ Comorbidity factors:

• Age ≥ 75 years at the time of enrollment;

• Patients with congestive heart failure (New York Heart Association Class III/IV);

• Patients with unstable angina pectoris;

• Patients with severe chronic obstructive pulmonary disease, defined as an FEV1 ≤ 50% of predicted, requirement for chronic oxygen therapy, or a resting PO₂ ≤ 60 mmHg;

• Patients with left ventricular ejection fraction ≤ 30%;

• Patients with recent myocardial infarction (within 2 to 6 weeks);

• Patients with coronary artery disease with ≥ 70% stenosis in two or more major vessels;

• Planned coronary artery bypass grafting or valve replacement surgery within 31 to 60 days following the procedure.

⁃ Anatomical factors:

• Lesions located at or above the level of the second cervical vertebra (C2) or lesions that are surgically inaccessible below the clavicle;

• History of radical head and neck surgery or radiotherapy;

• Patients with limited cervical spine mobility;

• Patients with tracheostomy;

• History of vocal cord paralysis or laryngectomy;

• Patients with contralateral recurrent laryngeal nerve palsy;

• Patients with restenosis following previous carotid endarterectomy;

• Patients with severe stenosis or occlusion of the contralateral carotid artery;

• Severe tandem lesions that can be covered by a single stent.