Symptomatic intracranial atherosclerotic stenosis
Conditions
Interventions
Experimental group:drug eluting balloon catheter
Sponsors
The First Affiliated Hospital of USTC (Anhui Probincial Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age from 18 to 80 years; 2. The degree of symptomatic intracranial artery stenosis was between 70% and 99%; 3. The stenosis vessels are located in internal carotid artery (intracranial segment), middle cerebral artery, basilar artery, vertebral artery (intracranial segment) or its branches; 4. The stenosis of intracranial artery to be treated is single lesion; 5. The patient has at least one risk factor of atheromatous plaque, including previous or existing hypertension, diabetes, hyperlipidemia, smoking; 6. mRS <= 2 points before entering the group; 7. Patients or their guardians can understand the purpose of the trial, voluntarily participate in and sign the written informed consent, and can accept the follow-up.
Exclusion criteria
Exclusion criteria: 1. Acute ischemic stroke occurred in the past two weeks; 2. Intracranial hemorrhage (cerebral parenchyma hemorrhage, massive subarachnoid hemorrhage, subdural / extradural hemorrhage) occurred within 3 months; 3. Hypertension beyond the control of drug treatment (systolic blood pressure >= 180mmHg or diastolic blood pressure >= 110mmHg); 4. Intracranial tumor, aneurysm or arteriovenous malformation; 5. The target lesion has been treated with stent implantation before; 6. Patients who are known to be allergic to heparin, rapamycin, contrast agents, aspirin, clopidogrel and anesthetics; 7. With a history of gastrointestinal hemorrhage within 6 months before signing the informed consent, so it was difficult to carry out antiplatelet therapy; 8. Platelet 250umol/L; 10. International standardization ratio (INR) is greater than 1.5; 11. Pregnant or lactating women, or planned pregnancy within one year; 12. The expected life is less than 1 year; 13. Participation in clinical trials of other drugs or devices is not completed; 14. Angiography showed intracranial artery stenosis caused by artery dissection, arteritis and thrombus; 15. Angiography showed that the vascular route was tortuous, and the test instrument could not reach the target position or could not be recovered; 16. Non responsible intracranial and extracranial stenosis was more than 70%; 17. Other conditions in which the patient is not considered suitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Restenosis rate of target lesions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of device;Success rate of operation;Incidence rate of Device defect;Mean lumen diameter stenosis 6 months after operation;The incidence of stroke in 30 days, 6 months and 12 months after operation;Mortality at 30 days, 6 months and 12 months after operation;Restenosis rate of target lesions 12 months after operation;Incidence rate of adverse event and Serious adverse event; | — |
Countries
China
Contacts
Public ContactXinfeng Liu
The First Affiliated Hospital of USTC (Anhui Probincial Hospital)
Outcome results
None listed