Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis (BASIS)

This is an interventional treatment trial for Intracranial Artery Stenosis focused on measuring ICAD, Intracranial Artery Stenosis, Ischemic Stroke, TIA, Angioplasty, Aggressive Medical Care Read More

Inclusion Criteria:

1. Males or females between 35 and 80 years of age.
2. Subjects with primary or recurrent symptomatic intracranial arteriosclerosis (stroke or transient ischemic attack within 21 days before enrollment, with at least one antithrombotic drug and/or vascular risk factors controlled);
3. Confirmed by DSA: a major intracranial artery (including anterior and posterior circulation, the anterior and posterior circulation lesions include: the terminal internal carotid artery (segments C4-C7), the M1 segment of the middle cerebral artery, the V4 segment of the vertebral artery, and the basilar artery) stenosis between 70% and 99%, (measured by WASID method), and corresponding to clinical symptoms; lesion length≤10mm, diameter≥1.5mm, and the distal blood vessel is normal. (For the curvature and angle of the lesion, the investigator decides whether it is included in the study according to the actual situation of the Subject);
4. Those who voluntarily participate in the study and sign informed consent form.

Exclusion Criteria:

1. Those who have surgery within 30 days or plan to perform major surgery within 90 days (surgery grade 3 and above);
2. Those who received thrombolytic therapy within 24 hours before enrollment;
3. Those with increased neurological symptoms within 24 hours before enrollment;
4. Subjects of acute ischemic stroke within 2 weeks before enrollment;
5. In addition to the target vessel and main blood supply artery, there are other intracranial artery stenosis more than 70%;
6. When there is a stenosis in the main blood supply artery of the target vessel, the stenosis should be excluded by more than 50%. For example, when the lesion is located in the middle cerebral artery, the ipsilateral internal carotid artery stenosis should be excluded by >50%; when the lesion is located in the basilar artery, the dominant side vertebral artery stenosis >50% should be excluded; non-responsible vascular extracranial artery more than 70% should be excluded; Balanced vertebral artery stenosis, if there is >70% stenosis in the contralateral vertebral artery at the same time, it should be excluded (because it is impossible to determine which side is the responsible vessel, and the contralateral stenosis also has a potential risk of vascular events.). The following are not exclusions: contralateral vertebral artery terminates posteroinferior cerebellar artery (PICA), dysplasia or slender, and contralateral vertebral artery is dominant vertebral artery.
7. The subjects with tandem lesions or stroke due to perforator artery occlusion;
8. The mRS baseline score of disabling stroke is more than 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. The target vessel is severely calcified and closely related to stenosis;
11. It is suspected that the ischemic event is due to embolism or arterial embolism from the extracranial segment (including ipsilateral chest or neck vascular occlusive disease) or potential cardiogenic embolism (e.g. atrial fibrillation, mitral stenosis, patent foramen ovale, left ventricular thrombus, myocardial infarction within 6 weeks, etc.);
12. There are intracranial tumors, aneurysms or intracranial arteriovenous malformations;
13. Intracranial hemorrhage within the past 3 months, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hemorrhage and subdural hemorrhage, etc.;
14. An angioplasty procedure (including balloon dilatation, stenting, or endarterectomy) in a previous target vessel or its primary blood supply artery, or a planned stenting procedure;
15. Those who cannot receive dual antiplatelet therapy because of other dieases;
16. Vascular tortousity cannot stabilize the establishment of vascular access;
17. Those who are allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and balloon components;
18. Hemoglobin is lower than 100g/L, platelet count is less than 100×109/ L, international normalized ratio (INR) is more than 1.5 (irreversible), coagulation disorders or uncorrectable bleeding factors;
19. Severe liver and kidney dysfunction, ALT is more than 3 times normal value upper limit or AST is more than 3 times normal value upper limit, serum creatinine increased more than 2 times normal value upper limit;
20. Pregnant and lactating women;
21. Subjects with renal artery, radial artery, and cardiac coronary artery requiring concurrent intervention;
22. The survival expectation is less than 1 year;
23. Those who are unable to complete follow-up because of mental illness, cognitive or emotional disorders;
24. All subjects who are participating in other drug/medical device clinical trials and have not completed the programme requirements;
25. Subjects who, in the opinion of the investigators, should not participate in the study.