Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis

Exclusion Criteria

• •1. Surgery within the past 30 days or plan to receive ≥ 3-grade surgery within 90 days;
• •2. Thrombolytic therapy within 24 hours before enrollment;
• •3. Neurological deficits worsen within 24 hours before enrollment;
• •4. Acute ischemic stroke onset within 14 days before enrollment;
• •5. Other intracranial arteries with severe stenosis (70-99%) besides the target artery and its supplying artery;
• •6. Target artery's supplying artery stenosis \> 50%. For example, patient with MCA severe stenosis (target artery) and the ipsilateral ICA stenosis \> 50% should be excluded; patient with BA severe stenosis (target artery) and the dominant VA stenosis \> 50% should be excluded; the patient with extracranial artery (non-lesion side) stenosis \> 70% should be excluded; For patients with balanced VA, if bilateral VA stenosis \> 70% at the same time, should be excluded (unable to determine which VA is the lesion artery). However, if patient's dominant VA is the lesion artery with a dysplasia or slender contralateral VA or a non-dominant contralateral VA terminating at posteroinferior cerebellar artery, should not be excluded.
• •7. Participant with perforator stroke (except for severe stenosis of supplying artery combined with hemodynamic compromise or poor collaterals) 12;
• •8. Baseline modified Rankin Scale ≥ 3;
• •9. Non-atherosclerotic diseases (e.g., arterial dissection, moyamoya disease, vascular inflammatory lesions caused by infection, autoimmune diseases, post-irradiation, postpartum status; developmental or genetic abnormalities such as fibromuscular dysplasia, sickle cell anemia, suspected vasospasm);
• •10. Target artery with severely calcified and adjacent to stenosis;
• •11. Suspected ischemic event caused by embolism or the arterial embolism from extracranial segment (ipsilateral chest or neck vascular occlusive disease) or potential cardioembolism (e.g., atrial fibrillation, mitral stenosis, patent foramen ovale, left ventricular thrombus, myocardial infarction within 6 weeks, etc.);
• •12. Coexistent with Intracranial tumors, aneurysms or intracranial arteriovenous malformations;
• •13. Intracranial hemorrhage within the past 3 months, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hemorrhage or subdural hemorrhage, etc.;
• •14. Angioplasty procedure (including balloon dilatation, stenting, or endarterectomy) performed at the original target vessel or its primary supplying artery, or a planned stenting procedure;
• •15. Unable to receive dual antiplatelet therapy due to other diseases;
• •16. Tortuous vascular approach that cannot be stabilized to obtain vascular access;
• •17. Allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and balloon components;
• •18. Hemoglobin \< 100g/L, platelet count \< 100×109/ L, international normalized ratio (INR) \>1.5 (irreversible), Coagulation dysfunction or uncorrectable bleeding factors;
• •19. Severe liver or kidney dysfunction. ALT \> three-fold higher than the upper limit of normal value or AST \> three-fold higher than the upper limit of normal value, or serum creatinine \> two-fold higher than the upper limit of normal value;
• •20. Pregnant and lactating women;
• •21. Participants with renal artery, radial artery, and cardiac coronary artery requiring concurrent intervention;
• •22. Expected survival expectation is less than\< 1 year;
• •23. Unable to complete follow-up due to mental illness, cognitive or emotional disorders;
• •24. Participants participating in other drug/medical device clinical trials who have not yet completed the program requirements;
• •25. Participants are not suitable for BASIS trial per investigator's opinion.