symptomatic intracranial atherosclerotic stenosis
Conditions
Interventions
trial group:Intracranial balloon dilatation catheter coated with rapamycin was used for intravascular therapy
Control group:Neurovascular balloon 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. Symptomatic intracranial artery stenosis, the degree of intracranial artery stenosis measured by cerebral angiography was between 70-99% (WASID method); 3. The stenosis vessels were 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 patients had at least one risk factor for atherosclerotic plaque, including past or existing hypertension, diabetes, hyperlipidemia, hyperuric acid, hyperhomocysteine, smoking, and alcohol consumption; 6. mRS <= 2 scores 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 accept follow-up.
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 medication (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 cause the test instrument to be difficult to reach the target position or difficult to recover; 8. Patients with > 50% stenosis after predilation of target lesions or unstable blood flow at the distal end of target lesions, or severe dissection after predilation (such as D, E, F type dissection) with poor patency of blood vessels at the distal end of target lesions; 9. Patients with known allergy to heparin, rapamycin, contrast agent, aspirin, clopidogrel, and anesthetic; 10. There was a history of gastrointestinal bleeding within 6 months before signing the informed consent, and antiplatelet therapy was difficult; 11. Platelet 3.0 mg/dL (264 µmol/L)), severe liver insufficiency (ALT or AST more than 3 times the normal value), and malignant tumors; 17. Severe calcification lesions and severe angulation lesions; 18. Other conditions for which the investigator considered the patient unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Restenosis rate of target lesion at 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of stroke events at 30 days, 6 months and 12 months after surgery;device success rate;Success rate of operation;The mean stenosis degree of lumen diameter was measured 6 months after operation;Target lesion restenosis rate at 12 months after surgery; | — |
Countries
China
Contacts
Public ContactJianmin Liu
Shanghai Changhai Hospital
Outcome results
None listed