Immediate angioplasty for severe stroke caused by narrowed arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, open-label, randomized controlled trial evaluates the effectiveness of immediate angioplasty, with or without stenting, in patients suffering from acute ischemic stroke due to severe intracranial atherosclerotic stenosis. Participants will be randomly assigned to receive either the angioplasty intervention along with the best medical treatment or the best medical treatment alone. The primary outcome is the proportion of patients achieving a favorable functional outcome, measured by the modified Rankin scale at 90 days post-treatment. The study aims to enroll 412 participants to assess the potential benefits of this intervention.

Why it matters

Who can join: the full rules

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).

Where it's running

• Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  Guangzhou, Guangdong, China Recruiting
• Shenzhen Hospital of Southern Medical University
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Principal investigator: Yamei Tang, M.D., Ph.D. — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Study coordinator: Xinguang Yang, M.D.
• Email: yangxinguang0926@163.com
• Phone: 86-20-81332619

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.