Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase
Not applicable
Started
2025-05-08
Last updated
2025-05-25
Condition(s) studied
Stroke, Acute Ischemic
Investigational drug(s) / intervention(s)
Immediate angioplasty
Immediate angioplasty: See arm/group descriptions.
Study summary
A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial that aims to evaluate the effect of immediate angioplasty (with or without stenting) for acute ischemic stroke (AIS) with severe intracranial atherosclerotic stenosis (ICAS) in improving the 90-day functional outcome.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Aged 18 years or older.
2. Diagnosed with AIS and baseline NIHSS ≥6.
3. Pre-stroke mRS ≤2.
4. Time from symptom onset to randomization ≤ 24 hours; the onset time refers to "Last Known Well" (LKW).
5. Non-contrast CT ASPECTS score ≥6.
6. CTA confirmed severe ICAS (70-99%) of the intracranial segment of the internal carotid artery, or M1 or M2 segment of the middle cerebral artery, and is presumed to be responsible for the stroke.
7. Informed consent signed by the patient or authorized representative.
Exclusion Criteria:
1. Normal diameter of the culprit vessel \<2.0 mm.
2. Isolated perforator artery infarction (except for combined cortical hypoperfusion).
3. Hemorrhagic stroke within the past 90 days.
4. Cerebrovascular conditions such as vasculitis, moya-moya disease, arterial inflammatory stenosis, vasospasm, traumatic dissection, etc..
5. Severe calcification at the stenosis site, where expected residual stenosis ≤50% cannot be achieved with procedure.
6. Known cardiac thrombus source (e.g., atrial fibrillation, patent foramen ovale, infective endocarditis).
7. INR \>1.7 when using warfarin; coagulation dysfunction or uncorrectable bleeding factors.
8. Platelet count \<50×10\^9/L.
9. Intracranial hemorrhage confirmed by CT or MRI.
10. Women who are pregnant or breastfeeding.
11. Participation in other intervention clinical trials.
12. Known severe renal insufficiency with glomerular filtration rate \<30 ml/min or blood creatinine \>220 μmol/L (2.5 mg/dl).
13. Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast.
14. Aortic dissection.
15. Concomitant intracranial tumor (except for meningioma \<10mm) or arteriovenous malformation.
16. Severe vascular tortuosity, difficult access for intervention, or inability to complete endovascular treatment.
17. Any active bleeding or recent bleeding in the last 1 month.
18. SBP\>185 mmHg or DBP\>110 mmHg refractory to treatment.
19. Anticipated life expectancy \<3 months (e.g., malignancy, severe cardiopulmonary disease, etc.).
20. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).
Primary outcome measure(s)
The modified Rankin Scale (mRS) 0-2 — 90(±7) days The proportion of the mRS 0-2 at 90 days.
Trial sites (2)
Facility
City
Region
Status
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou
Guangdong
Recruiting
Shenzhen Hospital of Southern Medical University
Shenzhen
Guangdong
Recruiting
More Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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