Study on the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets

Inclusion Criteria:

• Age ≥ 18 years;

• Patients with internal carotid artery stenosis, meeting at least one of thefollowing conditions:

• Asymptomatic carotid artery stenosis: Stenosis severity > 70%;

• Symptomatic carotid artery stenosis: Stenosis severity > 50%, with one or more ofthe following symptoms occurring within 180 days prior to the procedure: transientischemic attack (TIA), transient visual obscurations (TVO), or mild/non-disablingstroke;

• Common carotid artery diameter > 6 mm, and meets the required vascular diameter forcarotid artery stenting;

• The participant or their legal guardian is able to understand the purpose of thetrial, voluntarily consent to participation, sign an informed consent form, and iswilling to comply with follow-up requirements as outlined in the study protocol.

Exclusion Criteria:

• Anatomical Exclusion Criteria:

• Patients with extensive atherosclerotic plaques in the proximal common carotidartery, which hinder safe surgical manipulation;

• Patients with lesions in the common carotid artery access area or its proximalsegment;

• Patients with the common carotid artery bifurcation located < 5 cm from theclavicular margin;

• Patients with tandem severe stenosis or occlusion at the target lesion site;

• Patients who have previously received stent or graft implantation in the ipsilateralcarotid artery;

• Patients with bilateral carotid artery stenosis requiring intervention on bothsides;

• Patients with acute or subacute thrombosis, arteriovenous malformations, or otherabnormal vascular structures in the target lesion or adjacent regions;

• Patients with severe calcification or tortuosity at the target lesion site, makingit difficult to deliver devices to the intended location;

• Patients with concomitant severe symptomatic stenosis in other vascular territories,including intracranial or extracranial arteries;

• Patients who have experienced an ischemic stroke within the past 3 months, which mayimpact endpoint evaluation;

• Patients with a history of spontaneous intracranial hemorrhage within the past 12months;

• Patients diagnosed with carotid artery dissection;

• Patients with carotid stenosis due to non-atherosclerotic causes;

• Patients with other cardiovascular conditions that may predispose to embolism,including left ventricular aneurysm, cardiomyopathy, mechanical aortic or mitralvalves, infective endocarditis, mitral stenosis, atrial septal defect, atrial septalaneurysm, or left atrial myxoma;

• Patients with central nervous system disorders, including cranial nerve impairment,which could confound endpoint evaluation (e.g., severe dementia, secondary epilepsy,etc.);

• Patients with chronic atrial fibrillation;

• Patients with paroxysmal atrial fibrillation episodes within the past 6 months orthose requiring long-term anticoagulation therapy due to paroxysmal atrialfibrillation;

• Patients who have had a myocardial infarction within the last 6 months;

• Patients who have undergone or plan to undergo coronary artery bypass grafting (CABG), endovascular stenting procedures, or heart valve surgeries within 90 daysprior to the procedure, which may interfere with endpoint evaluation;

• Patients with active bleeding tendencies or significant coagulation disorders;

• Patients with a history of gastrointestinal bleeding that could interfere withantiplatelet therapy;

• Patients with preoperative liver or renal dysfunction, defined as alanineaminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding 5 timesthe upper limit of normal, or serum creatinine (Cr) > 3.0 mg/dL (265.2 μmol/L);

• Patients with known hypersensitivity to contrast agents, anticoagulants,antiplatelet medications, or materials used in stent delivery systems (e.g.,nitinol, PTFE, nylon-based polymers);

• Patients with intracranial or other malignancies;

• Patients with a life expectancy of less than 3 years;

• Women who are planning pregnancy, pregnant, or breastfeeding;

• Patients participating in another clinical trial or those who have not withdrawn orbeen excluded from a trial within the last 3 months of the screening period;

• Other patients who, in the investigator's opinion, are deemed unsuitable forinclusion in the study