Symptomatic intracranial atherosclerotic stenosis
Conditions
Interventions
Experimental group:Drug-eluting balloon catheter for the treatment of patients with symptomatic intracranial atherosclerotic stenosis
Sponsors
Henan Provincial People' Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years (including 80 years old); 2. The severity of symptomatic intracranial artery stenosis was between 70% and 99% by cerebral angiography (wasid method); 3. Patients with recurrent symptoms (stroke and transient ischemic attack) or intracranial artery stenosis combined with distal hypoperfusion (abnormal rCBF or rCBV) after conservative treatment; 4. The stenotic vessels were located in the internal carotid artery (intracranial segment), middle cerebral artery, vertebral artery (intracranial segment), basilar artery, and the distal segment was normal; 5. The intracranial artery stenosis needed to be treated was a single lesion; 6. The diameter of intracranial artery to be treated was more than or equal to 1.0 mm; 7. After pre-dilation, it must meet: forward blood flow TICI level 3; after pre-dilation, the guide wire is indwelled and observed for 5 minutes, and the residual stenosis is still <=50%; unrestricted blood flow type dissection; 8. patients had at least 1 risk factors for atheromatous plaque, including past or existing hypertension, diabetes, hyperlipidemia, and smoking; 9. MRS <= 3 points; 10. Patients or their guardians can understand the purpose of the trial, voluntarily participate and sign a written informed consent, and can accept follow-up.
Exclusion criteria
Exclusion criteria: 1. The target lesion was in stent restenosis; 2. There were more than 50% stenosis of large intracranial vessels outside the responsible vessels; 3. Intracranial hemorrhage (cerebral parenchymal hemorrhage, massive subarachnoid hemorrhage, subdural / epidural hemorrhage) occurred within 3 months; 4. Acute ischemic stroke occurred in the past two weeks; 5. Non atherosclerotic stenosis: such as arterial dissection, Moya Moya disease, vasculitis, radiation vascular disease or fibromuscular dysplasia; 6. Severe calcification, angulation and Mori type C lesions, as well as congenital development of vascular slender and fenestration; 7. Combined with intracranial tumor, aneurysm or intracranial arteriovenous malformation; 8. There are risk factors that may lead to cardiac embolism, such as fibrillation, left ventricular thrombosis, myocardial infarction within 6 weeks, etc; 9. Hypertension that cannot be controlled by medication (continuous systolic blood pressure >=180 mmHg or diastolic blood pressure >= 110 mmHg); 10. severe Complications or unstable conditions, such as severe heart failure, lung failure or renal failure (serum creatinine > 3.0mg/dL (264µmol/L) or glomerular filtration rate (GFR) 1.5, there are bleeding factors that cannot be corrected; 14. Antiplatelet / anticoagulant therapy is not available, and there are contraindications to anesthetics and contrast agents; 15. Angiography showed that the vascular path was tortuous, and it was difficult to reach the target position or recover the test instrument; 16. Patients with known allergy to heparin, paclitaxel, contrast agent, aspirin, clopidogrel and anesthetics; 17. The life expectancy is less than 1 year; 18. Those who have not completed the clinical trials of other drugs or devices; 19. Pregnant or lactating women, or planning to get pregnant within one year; 20. The researchers considered that the patients were not suitable for other conditions of the enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Restenosis rate of target lesions ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate postoperative imaging success rate;Device success rate;Surgical success rate;target lesion lumen stenosis degree;Restenosis rate of target lesions ;The incidence of recurrence of ischemic stroke and transient cerebral ischemia (TIA) in the responsible vascular area ;Responsible for the incidence of extravascular ischemic stroke and transient cerebral ischemia (TIA);The incidence of non-stroke bleeding (epidural hemorrhage, intradural hemorrhage or other major systemic hemorrhage) ;mortality;Product performance evaluation;Incidence of device defects;Serious adverse event rate;adverse event rate;The incidence of stroke events (including hemorrhagic or ischemic stroke, transient cerebral ischemia) ; | — |
Countries
China
Contacts
Public ContactLi Tianxiao
Henan Provincial People's Hospital
Outcome results
None listed