acute ischemic stroke
Conditions
Interventions
Experimental group:Submaximal balloon dilation + medical management
Control group:medical management only
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 30-80 years; 2. Symptomatic atherosclerotic large artery stenosis in the intracranial segment (intracranial segment of the internal carotid artery (C4-C7 segments), MCA-M1 segment, vertebral artery V4 segment, basilar artery), with 70%-99% stenosis confirmed by DSA; 3. Mild stroke with positive DWI within 1 week of onset, with NIHSS score =4; 4. If the patient’s minor stroke worsens (NIHSS score increases by >=2 points), the onset time is calculated based on the time the symptoms worsened; for high-risk TIA patients, the onset time is calculated based on the last symptom episode; 5. Target vessel diameter range: 2.0mm to 4.5mm, target lesion vessel stenosis length: =6 or pc-ASPECT score >=8); 8. The patient or their family understands the purpose and requirements of this study and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Allergy to contrast agents; 2. Stenosis related to non-atherosclerotic diseases: arterial dissection, moyamoya disease, arteritis, etc.; 3. Target lesion-side perforating branch lesions (defined as infarction caused by perforating branch occlusion, presenting as simple basal ganglia or brainstem/thalamic infarction despite MCA or BA stenosis); 4. Presence of =70% stenosis in the extracranial segment of the target lesion side; 5. Prior endovascular treatment on the same side vessel; 6. Presence of intracranial aneurysm, tumor, or vascular malformation; 7. Any form of ipsilateral intracranial hemorrhage within 3 months and contralateral intracranial hemorrhage within 2 weeks; 8. Patients with atrial fibrillation, severe cardiac dysfunction, or liver and kidney insufficiency; those with tumors or severe diseases with an expected survival of less than 1 year; 9. Hemoglobin below 100 g/L, platelet count less than 100×10^9/L, international normalized ratio (INR) >1.5 (irreversible), coagulation disorders, or uncorrectable bleeding factors; 10. Uncontrolled hypertension: systolic blood pressure >185 mmHg and/or diastolic blood pressure >110 mmHg; 11. Poorly controlled blood glucose (random blood glucose >22.2 mmol/L); 12. History of major surgery within 30 days prior to enrollment (referring to level III or higher surgical procedures, such as radical gastrointestinal tumor surgery, joint replacement, partial nephrectomy, adrenal tumor resection, total cystectomy, and other surgeries involving important organs or with a high risk of complications) or a surgical plan within 90 days after enrollment; 13. Pregnant or breastfeeding women; 14. Other situations deemed by the investigator to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ischemic stroke events in the target vessel territory within 1 year after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ischemic stroke events in the target vascular territory within 30 days after randomization;mRS difference within 90 days after randomization;Proportion of patients with radiologically assessed restenosis of >=70% in the target vessel treated with interventional therapy within 1 year after enrollment;Proportion of patients undergoing revascularization therapy (including emergent and elective procedures such as mechanical thrombectomy, balloon angioplasty, and stenting) for ischemic stroke events within 1 year after enrollment;Any intracranial hemorrhage within 24h after endovascular therapy and symptomatic ICH within 7 days after intervention;Complications related to interventional surgery;All-cause mortality events within 30 days after enrollment and from 30 days to 1 year; | — |
Countries
China
Contacts
Public ContactYi Yang
The First Hospital of Jilin University
Outcome results
None listed