Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis

Recruiting now · Not applicable

Conditions studied: Stroke, Acute Ischemic

In brief

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.

Key facts

Study ID

NCT06437600

Run by

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

People needed

412

Starts

2025-05-08

Expected to finish

2029-12-01

Last updated by the study team

2025-05-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 years or older.
• Diagnosed with AIS and baseline NIHSS ≥6.
• Pre-stroke mRS ≤2.
• Time from symptom onset to randomization ≤ 24 hours; the onset time refers to "Last Known Well" (LKW).
• Non-contrast CT ASPECTS score ≥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.
• Informed consent signed by the patient or authorized representative.

You may not qualify if…

• Normal diameter of the culprit vessel <2.0 mm.
• Isolated perforator artery infarction (except for combined cortical hypoperfusion).
• Hemorrhagic stroke within the past 90 days.
• Cerebrovascular conditions such as vasculitis, moya-moya disease, arterial inflammatory stenosis, vasospasm, traumatic dissection, etc..
• Severe calcification at the stenosis site, where expected residual stenosis ≤50% cannot be achieved with procedure.
• Known cardiac thrombus source (e.g., atrial fibrillation, patent foramen ovale, infective endocarditis).
• INR >1.7 when using warfarin; coagulation dysfunction or uncorrectable bleeding factors.
• Platelet count <50×10\^9/L.
• Intracranial hemorrhage confirmed by CT or MRI.
• Women who are pregnant or breastfeeding.
• Participation in other intervention clinical trials.
• Known severe renal insufficiency with glomerular filtration rate <30 ml/min or blood creatinine >220 μmol/L (2.5 mg/dl).
• Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast.
• Aortic dissection.
• Concomitant intracranial tumor (except for meningioma <10mm) or arteriovenous malformation.
• Severe vascular tortuosity, difficult access for intervention, or inability to complete endovascular treatment.
• Any active bleeding or recent bleeding in the last 1 month.
• SBP>185 mmHg or DBP>110 mmHg refractory to treatment.
• Anticipated life expectancy <3 months (e.g., malignancy, severe cardiopulmonary disease, etc.).
• 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).

Where it is running

• Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China (enrolling)
• Shenzhen Hospital of Southern Medical University — Shenzhen, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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