Non-acute symptomatic intracranial atherosclerotic stenosis
Conditions
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 to 80 years old; 2. Symptomatic intracranial artery stenosis. The stenosis degree of intracranial artery diameter is between 70% and 99% by visual inspection under intracranial angiography. 3. The stenotic vessels are located in internal carotid artery (intracranial segment), middle cerebral artery (M1, M2), basilar artery and vertebral artery (intracranial segment); 4. Intracranial arterial stenosis requiring interventional therapy is a single lesion; 5. Patients have at least one risk factor for atherosclerotic plaque, including past or existing hypertension, diabetes, hyperlipidemia and smoking; 6. mRS<=2 score <= 2 before joining the group; 7. Patients or their guardians can understand the purpose of the trial, voluntarily participate and sign a written informed consent form, and can be followed up.
Exclusion criteria
Exclusion criteria: 1. Acute ischemic stroke occurred in the last 4 weeks; 2. Intracranial hemorrhage (cerebral parenchymal hemorrhage, subarachnoid hemorrhage, subdural/extradural hemorrhage) occurred within 3 months; 3. Uncontrollable hypertension after drug treatment (systolic blood pressure >=180 mmHg or diastolic blood pressure >= 110mmhg); 4. Complicated with intracranial tumor, aneurysm or intracranial arteriovenous malformation; 5. The target lesions had been implanted with stents in the past; 6. Patients who are known to be allergic to heparin, paclitaxel, contrast agents, aspirin, clopidogrel and anesthetics; 7. There is a history of gastrointestinal bleeding within 6 months before signing the informed consent form, and it is difficult to carry out antiplatelet treatment; 8. Platelet 250 umol/L; 10. The International Standardization Ratio (INR) is greater than 1.5; 11. Pregnant or lactating women, or those who plan to become pregnant within one year; 12. Life expectancy is less than 1 year; 13. Those who have not completed clinical trials of other drugs or devices; 14. Angiography shows intracranial artery stenosis caused by arterial dissection, arteritis and thrombosis; 15. Angiography shows that the vascular path is tortuous, and it is difficult for the test instrument to reach the target position or recover; 16. Other situations where the researcher thinks that the patient is not suitable for grouping.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Restenosis rate of target lesion at 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean stenosis degree of lumen diameter 6 months after operation;Restenosis rate of target lesions 12 months after operation;Incidence of stroke at 30 days, 6 months and 12 months after operation;Instrument success rate;Operation success rate;Incidence of serious adverse events and incidence of adverse events;Mortality at 30 days, 6 months and 12 months after operation; | — |
Countries
China
Contacts
Public ContactJianmin Liu
Shanghai Changhai Hospital
Outcome results
None listed