Stroke
Conditions
Interventions
Control group(standard medical treatment):None
Endovascular treatment group(endovascular treatment + standard medical treatment):None
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
30 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 30-85 years; 2. Patients with primary or recurrent sICAS, defined as those who have experienced a new transient ischemic attack (TIA) within the past 90 days or an ischemic stroke caused by severe atherosclerotic stenosis (70%-99%) of a major intracranial artery, occurring between 14 days and 90 days prior to enrollment, and who have received at least one antithrombotic agent and/or standard medical management for vascular risk factors; 3. Severe atherosclerotic stenosis (70-99% as diagnosed by the WASID method via DSA), with a lesion length of =1.5 mm, and normal distal arteries, located in major intracranial arteries, including the C4-C7 segments of the distal internal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA), the basilar artery (BA), and the V4 segment of the vertebral artery (VA); 4. The patient or their legal representative has provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients scheduled to undergo major surgery (grade III or above) within the next 90 days or those who have undergone surgery within the past 30 days. 2. Patients who received thrombolytic therapy within the last 24 hours prior to enrollment. 3. Patients whose neurological deficits worsened within the last 24 hours prior to enrollment. 4. Occurrence of acute ischemic stroke within the last 14 days prior to enrollment. 5. Intracranial arterial stenosis of 70%–99% in arteries other than the target artery and its feeding arteries. 6. Stenosis exceeding 50% in the feeding artery of the target artery (e.g., severe MCA stenosis (target artery) with ipsilateral ICA stenosis >50%; severe BA stenosis (target artery) with dominant VA stenosis >50% should be excluded). Stenosis >70% in the extracranial artery on the non-target side should be excluded. Bilateral VA stenosis >70% in patients with balanced VAs (where the target VA cannot be identified) should be excluded. However, lesions in a dominant VA where the contralateral VA is hypoplastic or attenuated, or where the contralateral VA terminates as the posterior inferior cerebellar artery, are not excluded. 7. Perforator stroke events (except when stenosis >70% in the feeding artery is accompanied by poor collateral circulation or hemodynamic impairment). 8. Modified Rankin Scale (mRS) score of 4–6 at enrollment. 9. Intracranial arterial stenosis caused by non-atherosclerotic pathologies, including: arterial dissection, moyamoya disease, vasculitis, herpes zoster, varicella-zoster or other viral vasculopathies, neurosyphilis, any other intracranial infections, any intracranial stenosis associated with pleocytosis in cerebrospinal fluid, radiation-induced vasculopathy, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, benign CNS vasculopathy, postpartum vasculopathy, suspected vasospasm, suspected recanalized embolism, etc. 10. Severe calcification of the target artery or tandem stenosis. 11. Coexisting intracranial tumor, aneurysm, or intracranial arteriovenous malformation. 12. Patients with intracranial hemorrhage, including intraventricular, epidural, subarachnoid, parenchymal hematoma, or subdural hemorrhage, within 90 days prior to enrollment. 13. Patients who have undergone balloon angioplasty, endarterectomy, or stenting of the target lesion or its major feeding artery, or those scheduled for stenting. 14. Contraindications to dual antiplatelet therapy due to other medical conditions. 15. High suspicion of ischemic events due to embolism from extracranial arterial segments (e.g., occlusion of ipsilateral cervical/thoracic arteries) or cardioembolic sources, such as left ventricular thrombus, mitral stenosis, atrial fibrillation, myocardial infarction within 6 weeks, patent foramen ovale, etc. 16. Tortuous arterial anatomy preventing stable arterial access. 17. Allergy to aspirin, contrast agents, balloon components, clopidogrel, heparin, or anesthetics. 18. Severe hepatic impairment (ALT >3× upper limit of normal or AST >3× ULN) or severe renal impairment (serum creatinine >2× ULN). 19. Pregnant or lactating women. 20. Hemoglobin (Hb) 1.5 (irreversible), platelet count <100×10^?/L, coagulopathy, or irreversible bleeding tendency. 21. Patients requiring concurrent interventional treatment for radial, renal, or coronary artery disease. 22. Dementia or psychiatric conditions affecting the patient’s ability to reliably adhere to follow-up schedules. 23. Any
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any stroke event or death within 30 days after enrollment;Ischemic stroke events within the target vessel's blood supply area or target vessel revascularization from 30 days after enrollment to within 12 months.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Any stroke event or death occurring within 90 days of enrollment in the study within the blood supply area of the target vessel;Ischemic stroke events outside the blood supply area of the target vessel within 90 days of enrollment;Neurological function evaluation 90 days after treatment (modified Rankin Scale score);Any stroke event or death occurring within 12 months after enrollment in the study within the area supplied by the target vessel;Target vessel underwent revascularization within 12 months after enrollment;Any cerebrovascular event outside the target blood supply area within 12 months of enrollment;Neurological function evaluation 12 months after treatment (modified Rankin Scale score); | — |
Countries
China
Contacts
Public ContactChen Yangmei
The Second Affiliated Hospital of Chongqing Medical University
Outcome results
None listed