non-acute symptomatic intracranial atherosclerotic stenosis
Conditions
Interventions
Experimental group:Rapamycin drug coated intracranial balloon dilator catheter
Sponsors
Changhai Hospital of Shanghai
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 80 years; 2. Symptomatic intracranial artery stenosis, the degree of intracranial artery stenosis measured by cerebral angiography was between 70-99% (WASID method); 3. Stenosis vessels were located in internal carotid artery (intracranial segment), middle cerebral artery (M1, M2 segment), basilar artery, vertebral artery (intracranial segment); 4. Intracranial arterial stenosis requiring interventional treatment was a single lesion; 5. The patient had at least one risk factor for atherosclerotic plaque, including previous or existing hypertension, diabetes, hyperlipidemia, hyperurea, hyperhomocysteine, smoking, and alcohol consumption; 6. mRS<=2 points in screening period; 7. Patients or their guardians can understand the purpose of the study, voluntarily participate and sign a written informed consent, and can receive follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Acute ischemic stroke or major surgery within two weeks prior to screening; 2. Acute myocardial infarction occurred within 30 days before screening; 3. Intracranial hemorrhage (parenchymal hemorrhage, subarachnoid hemorrhage, subdural/external hemorrhage) occurred within 3 months; 4. Uncontrolled hypertension with medical treatment (systolic blood pressure >=180 mmHg or diastolic blood pressure >=110mmHg); 5. Complicated with intracranial tumor, intracranial aneurysm or intracranial arteriovenous malformation; 6. The target lesions had previously undergone stenting; 7. The angiography showed that the target vessel path was tortuous or other reasons would make it difficult for the test instrument to reach the target position or recover; 8. Patients with known allergy to heparin, rapamycin, contrast agent, aspirin, clopidogrel, and anesthetic; 9. The patient has a history of gastrointestinal bleeding within 6 months before signing the informed consent, and it is difficult to perform antiplatelet therapy; 10. Platelet 3.0mg/dL (264µmol/L)), severe liver insufficiency (ALT or AST more than 3 times the normal value), and malignant tumors; 17. Severe calcification and angulation lesions; 18. Other conditions for which the investigator considered the patient unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target restenosis rate at 6 months; | — |
Countries
China
Contacts
Public ContactLiu Jianmin
Outcome results
None listed