Aspiration with a super large bore catheter vs. stent retriever in anterior circulation large vessel occlusion

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, randomized trial compares two first-line endovascular approaches for acute ischemic stroke due to intracranial internal carotid or M1 occlusion. Participants are randomized to either aspiration with a super large bore catheter or a traditional stent retriever thrombectomy, with open-label treatment but blinded outcome assessment. Eligible patients are adults with moderate-to-severe neurologic deficit, favorable imaging, and treatment within 24 hours of onset; key safety and efficacy outcomes include 90-day functional status and early neurologic change. The study aims to enroll about 708 patients across roughly 30 centers in China. The primary endpoint is the overall modified Rankin Scale score at 90 days, with several secondary endpoints including mRS 0-2 at 90 days and NIHSS changes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years;
2. Clinically diagnosed with acute ischemic stroke, and pre-procedure imaging confirms that the culprit vessel is occlusion of the intracranial segment of the internal carotid artery and/or the middle cerebral artery M1 segment;
3. Pre-stroke modified Rankin Scale (mRS) score of 0-1;
4. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6;
5. Alberta Stroke Program Early CT Score (ASPECTS) ≥ 3;
6. Time from symptom onset to initiation of endovascular treatment (arterial puncture) \< 24 hours; symptom onset time is defined as the "last known well" time;
7. Intravenous thrombolysis and/or mechanical thrombectomy are performed according to local guidelines, and intravenous thrombolysis does not delay mechanical thrombectomy;
8. Written informed consent is obtained from the patient or a family member.

Exclusion Criteria:

1. Imaging shows acute or subacute intracranial hemorrhage (excluding microbleeds);
2. Imaging indicates an intracranial tumor (excluding meningiomas \<2 cm in diameter) or mass effect caused by a tumor, such as midline shift;
3. Cerebral embolism caused by infection or bacterial endocarditis;
4. The culprit vessel lesion is considered to be chronic atherosclerotic stenosis and occlusion;
5. Pre-procedure imaging suggests that the lesion is due to dissection;
6. Previous intracranial aneurysm or vascular malformation in the culprit vessel;
7. Presence of a life-threatening illness within 6 months that would prevent 3-month follow-up;
8. Pregnancy, psychiatric illness, severe hepatic or renal insufficiency, severe heart failure;
9. Concurrent participation in another clinical drug or device study;
10. Metastatic tumor;
11. Systemic infection;
12. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.

Where it's running

• Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Yueqi Zhu, MD — Shanghai Sixth Hospital Affiliated to Shanghai Jiaotong University School of Medicine
• Study coordinator: Yueqi Zhu, MD
• Email: zhuyueqi@sjtu.edu.cn
• Phone: 18930173115

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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.