symptomatic intracranial atherosclerotic stenosis
Conditions
Interventions
trial group:Rapamycin drug - coated intracranial stent was used for intravascular therapy
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Aged between 18 and 80; 2) Patients with symptomatic intracranial atherosclerotic stenosis who have failed to receive antiplatelet therapy or have poor collateral circulation compensation and have low perfusion in the responsible blood vessel supply area; 3) 2mm=70% and <=99% (WASID method); 5) The stenosis vessels were internal carotid artery (intracranial segment), middle cerebral artery, basilar artery, vertebral artery (intracranial segment); 6) Intracranial arterial stenosis requiring interventional treatment was a single lesion; 7) The patient had at least one or more risk factors for atherosclerotic plaques, including hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia, coronary heart disease, obesity, and smoking history; 8) mRS<=2 points before enrollment; 9) The onset time of the latest TIA was not limited or the onset time of the latest ischemic stroke was more than 2 weeks; 10) Patients or their guardians can understand the purpose of the study, voluntarily participate and sign a written informed consent, and can receive follow-up.
Exclusion criteria
Exclusion criteria: 1) Preoperative CT or MRI showed post-infarction hemorrhagic transformation in the target vessel area, or previous history of primary cerebral hemorrhage, or history of subarachnoid, subdural and epidural hemorrhage within 30 days before surgery, or chronic subdural hematoma >=5mm without treatment; 2) Major surgical procedures were performed within 30 days before surgery, or hospitalization surgery was planned within 6 months after surgery; 3) MRI after the last event indicated only perforating branch infarction in the target lesion area; 4) Uncontrolled hypertension with medication (systolic blood pressure >=180 mmHg or diastolic blood pressure >=110mmHg); 5) Complicated with intracranial tumor or intracranial arteriovenous malformation, or distal and proximal aneurysms of target vessels; 6) The target lesions had previously undergone stenting; 7) The angiography showed that the target lesions were seriously calcified, or the target vascular path was tortuous or other reasons would cause the test instrument to be difficult to reach the target lesion location; 8) The intracranial great vessels at the distal end of the target vessel or the intracranial and external great vessels at the proximal end of the target vessel have stenosis of more than 70%, and the responsible lesions cannot be identified. 9) Patients with complete target vessel occlusion; 10) Non-atherosclerotic stenosis: arterial dissection, Moyamoya disease (moya), vasculitis, active arteritis, etc.; 11) Patients suspected to be allergic to heparin, rapamycin, Nitinol, contrast agent, aspirin, clopidogrel, anesthetic; 12) Potential sources of cardiac thrombosis, such as atrial fibrillation, left ventricular thrombosis, and myocardial infarction within 30 days; 13) Patients with hemoglobin less than 100g/L, platelet count less than 100*10^9/L, International standardized ratio (INR) greater than 1.5 (irreversible), and tendency to hemorrhage that cannot be corrected; 14) Severe co-existing diseases or unstable diseases, such as severe heart failure, lung failure or kidney failure (serum creatinine >3.0mg/dL (264umol/L)), severe liver insufficiency (ALT or AST more than 3 times the normal value), and malignant tumors; 15) Pregnant or lactating women, or those who plan to become pregnant within one year; 16) Life expectancy is less than 1 year; 17) Participating in clinical trials for other drugs or devices; 18) The patient had cognitive impairment or mental illness, and other conditions in which the investigator considered the patient unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Restenosis rate of target lesion 6 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| device success rate;Success rate of operation;Incidence of symptomatic intrastent restenosis (ISR) 6 months after surgery;Rankin score at 30 days, 6 months, and 12 months after surgery;Target lesion revascularization rate at 30 days, 31 days to 6 months, and 12 months after surgery; | — |
Countries
China
Contacts
Public ContactJianmin Liu
Shanghai Changhai Hospital
Outcome results
None listed