intracranial atherosclerotic stenosis (ICAS)
Conditions
Interventions
Drug coated balloon group:Dilation was performed using a drug-coated balloon (DCB)
Plain balloon group:Plain angioplasty
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-90 years; 2. sICAS, ineffective in intensive drug treatment or poor compensation of lateral limb circulation, with low perfusion in the supply area of responsible vessels; 3. Severe stenosis was confirmed by DSA (70%-99% stenosis according to WASID standard), and the target diameter of the diseased vessel was 2.0-4.0mm; 4. Basic mRS score <=2 points; 5. The patients voluntarily participated in the study, signed informed consent, complied with the trial protocol and were capable of regular follow-up examination.
Exclusion criteria
Exclusion criteria: 1. Intracranial non-atherosclerotic stenosis, including arterial dissection, moyamoya disease, vasculitis, radiotherapy-induced vascular lesions, and femoral dysplasia; 2. sICAS combined with severe stenosis of vessels in the extracranial segment, and other primary sICAS lesions or ISRs require concurrent treatment; 3. CT or MRI showed fresh infarction (DWI), large cerebral infarction (infarct > 1/2 of the middle cerebral artery supply area), intracerebral hemorrhage, subdural or epidural hemorrhage; 4. Severe tortuosity of blood vessels or other anatomical factors caused by the balloon catheter through difficult to place; 5. Pregnant or lactating patients; 6. Patients with atrial fibrillation, atrial myxoma and other possible cardiac embolism; 7. There are contraindications in the use of antiplatelet drugs or iodized contrast agents; 8. Severe liver injury: AST or ALT more than 3 times the normal value, cirrhosis; 9. Severe renal impairment: creatinine >=265umol/l; 10. Unable to tolerate general anesthesia due to insufficiency of other organs; 11. Severe dementia or mental disorders cannot be followed up in outpatient clinics; 12. Expected survival <1 year; 13. The patient participated in other studies, which conflicted with this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Restenosis rate of target vessels on DSA at 6-month follow-up; | — |
Countries
China
Contacts
Public ContactYang Ximeng
Beijing Hospital
Outcome results
None listed