The Efficacy and Safety of Intracranial Stent (Tonbridge) in Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis

Exclusion Criteria18

• Intracranial arterial stenosis caused by non-atherosclerotic lesions: such as arterial dissection, moyamoya disease, vasculitis, active arteritis, etc.;
• Preoperative MRI shows only perforator infarction in the target lesion;
• Preoperative CT or MRI indicates the presence of post-infarct hemorrhagic transformation in the target vascular, or a history of subarachnoid, subdural, and epidural hemorrhage within 30 days before procedure, or the presence of untreated chronic subdural hematoma (≥5mm);
• Severe calcification of target vessels; or target vessel tortuosity or other reasons will make experimental device difficult to reach the target lesion position;
• There is more than 70% stenosis in the distal intracranial large vessels or proximal intracranial and extracranial large vessels of the target vessels, and the presence of unidentified responsible lesions;
• Subjects have a major surgery within 30 days before procedure or intend to be hospitalized for other procedure within 6 months after procedure;
• Intracranial tumors or intracranial arteriovenous malformations, or distal and proximal target vessels combined with aneurysms;
• The target lesion has a history of stent implantation;
• It is suspected that there is severe allergy or contraindication to aspirin, clopidogrel, heparin, contrast media, nitinol and other drugs and devices related to endovascular therapy;
• There is an underlying source of cardiac thrombus, such as atrial fibrillation, left ventricular thrombus, myocardial infarction within 30 days;
• Subjects with an INR \> 1.5 or the presence of nonmodifiable bleeding factors;
• Medically uncontrolled severe hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg);
• Severe comorbid conditions or unstable conditions, such as severe heart failure, pulmonary failure, or renal failure (serum creatinine \>3.0 mg/dL (264μmol/L)), severe liver insufficiency (ALT or AST \>3 times normal), and malignancy;
• Life expectancy is less than two years;
• Women who are pregnant or breastfeeding;
• Subjects unable to complete follow-up due to cognitive impairment, mood disorder, or mental illness;
• Subjects who are enrolled in other clinical trials of drugs/devices and have not yet met the primary endpoint;
• Other circumstances which investigators do not consider are appropriate for intracranial stent treatment.