Symptomatic intracranial atherosclerotic stenosis
Conditions
Interventions
Test Group:Intracranial stents coated with rapamycin were used
Control group:Wingspan mounting system were used
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age 18 to 80 years old; 2) Patients with symptomatic intracranial atherosclerotic stenosis who have failed antiplatelet therapy or 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 in the internal carotid artery (intracranial segment), middle cerebral artery, basilar artery, and vertebral artery (intracranial segment); 6) Intracranial arterial stenosis requiring interventional treatment was a single lesion; 7) The patients had at least one or more risk factors for atherosclerotic plaque, including hypertension, diabetes, hyperlipidemia, hyperhomocysteinemia, coronary heart disease, obesity, and smoking history; 8) mRS <=2 points before enrollment; 9) The onset time of the latest TIA is not limited or the onset of the latest ischemic stroke is more than 2 weeks; 10) Patients or their guardians can understand the purpose of the trial, voluntarily participate and sign a written informed consent, and can accept follow-up patients.
Exclusion criteria
Exclusion criteria: 1) Preoperative CT or MRI indicated post-infarction hemorrhage transformation in the target vascular area, or a history of primary cerebral hemorrhage, or a history of subarachnoid space, subdural and epidural blood within 30 days before surgery, or chronic subdural hematoma =5mm without treatment; 2) Have undergone major surgery within 30 days before surgery, or plan to undergo inpatient surgery within 6 months after surgery; 3) After the last event, MRI revealed 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 or proximal aneurysms of target vessels; 6) The target lesion has previously undergone stent implantation; 7) The angiography shows that the target lesion is severely calcified, or the target vascular path is tortuous or other reasons will cause the test instrument to be difficult to reach the target lesion location; 8) Stenosis of the distal intracranial or proximal intracranial or external macrovessels of the target vessels is greater than 70%, and there is no clear responsibility of the lesions; 9) Patients with complete target vessel occlusion; 10) Non-atherosclerotic stenosis: arterial dissection, Moyamoya disease (moya), vasculitis, active arteritis, etc.; 11) Identify patients who are allergic to rapamycin, Nitinol, aspirin and clopidogrel; 12) There is a potential source 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 a tendency to hemorrhage that cannot be corrected; 14) Severe concomitant or unstable conditions, such as severe heart failure, lung failure or kidney failure (serum creatinine >3.0mg/dL (264µmol/L)), severe liver insufficiency (ALT or AST more than 3 times the normal value), and malignant tumors; 15) Pregnant or lactating women, or those planning to become pregnant within one year; 16) Life expectancy is less than 1 year; 17) Participating in other drug or device clinical trials; 18) Operation errors occurred during the establishment of the access system and balloon expansion prior to the formal release of the stent, which affected the test outcome; 19) The patient has cognitive impairment or mental illness, and other conditions in which the investigator considers the patient unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The restenosis rate of target lesion at 6 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device Success rate;Operation success rate;Revascularization rate of target lesion within 30 days, 31 days to 6 months and 12 months after surgery;Modified Rankin score at 30 days, 6 months, and 12 months after surgery;Incidence of symptomatic intrastent restenosis (ISR) 6 months and 12 months after surgery;The restenosis rate of target lesion at 12 months after operation; | — |
Countries
China
Contacts
Public ContactLi gang
Shanghai East Hospital
Outcome results
None listed