Endovascular Treatment for Acute Large Vessel Occlusion With Ultra-Large Ischemic Core

NCT07791810 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital of Harbin Medical University

Phase

Not applicable

Started

2026-09-18

Last updated

2026-08-28

Condition(s) studied

AISStroke

Investigational drug(s) / intervention(s)

Patients assigned to the EVT group should undergo EVT as soon as possible, followed by BMM according to the current EVT guidelines.The medical group receives BMM alone. EVT is not performed in the medical group.

Patients assigned to the EVT group should undergo EVT as soon as possible, followed by BMM according to the current EVT guidelines.: EVT should be performed as soon as possible in patients randomized to the EVT group. Investigators and clinicians should make every effort to minimize delays related to pre-procedural preparation, with a target interval of no more than 60 minutes from randomization to arterial puncture. EVT in the EVT group can be performed with any thrombectomy device (NMPA approved) usually used at study site.

The medical group receives BMM alone. EVT is not performed in the medical group.: The administration of medications is at the treating physician's discretion (for example intravenous fibrinolysis, anticoagulants or antiplatelet) according to current AIS management guidelines but may NOT include any intra-arterial therapies.

Study summary

an investigator initiated, prospective, multicenter, randomized, open-label, blinded endpoint trial (PROBE)

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. ≥18 years. 2. Symptoms onset or Time last known well ≤ 24 h from randomization. 3. Acute ischemic stroke due to an occlusion of the intracranial internal carotid artery, M1 or proximal M2 segment of the middle cerebral artery confirmed by CTA or MRA. 4. NCCT or diffusion-weighted imaging (DWI) demonstrating ASPECTS ≤ 2 or infarct core volume (defined as rCBF \<30% on CTP) ≥ 100 mL. 5. Selection imaging performed ≤ 3 hours before randomization. 6. Pre-stroke mRS 0 - 1. 7. Informed consent form was signed. Exclusion Criteria: 1. Evidence of intracranial hemorrhage on CT/MRI, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, or subdural/epidural hemorrhage. 2. Cerebral midline shift or herniation, or other ventricular mass effect with midline shift as confirmed on CT/MRI. 3. Bilateral anterior circulation or acute multi-vessel occlusion involving both anterior and posterior circulation, confirmed by CTA or MRA. 4. Blood pressure \>185/110 mmHg and is refractory to medicine. 5. Known coagulopathy, with international normalized ratio (INR) \>1.7 or platelet count \<100×10⁹/L; 6. Current treatment with direct thrombin inhibitors or factor Xa inhibitors; 7. Patients with severe organ failure (cardiac, pulmonary, renal, or hepatic); 8. Concomitant malignancy or other conditions with life expectancy under 6 months; 9. Female who is known to be pregnant; 10. Prior endovascular attempt for this stroke;; 11. Currently participation in another clinical study; 12. Other circumstances that the investigator considers inappropriate for participation.

Primary outcome measure(s)

The primary efficacy endpoint is the mRS score at 90 days after randomization. — at 90 days after randomization.

Trial sites (1)

Facility	City	Region	Status
he First Affiliated Hospital of Harbin Medical University	Harbin	Hei Longjiang

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Official registry record

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.

View NCT07791810 on ClinicalTrials.gov ↗ ← All trials in China