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

NCT07791810 | Not Yet Recruiting DMC

• 1 other identifier: LARGE CORE-MT
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

AIS; Stroke

Keywords

LARGE CORE-MT; AIS; stroke

Outcome Measures

Primary Outcomes (1)

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

  at 90 days after randomization.

Secondary Outcomes (6)

• mRS score at 180 days after randomization.

  at 180 days after randomization.

• Proportion of mRS 0-2 at 90 days and 180 days after randomization.

  at 90 days and 180 days after randomization.

• Proportion of mRS 0-3 at 90 days and 180 days after randomization.

  at 90 days and 180 days after randomization.

• Proportion of early neurological improvement

  at day 7 (±1) or discharge (whichever is earlier).

• Infarct volume change from baseline NCCT at 7 (±1) days after randomization or discharge (whichever is earlier), or by MRI at 36 (±12) hours.

  at 7 (±1) days after randomization or discharge (whichever is earlier), or by MRI at 36 (±12) hours.

Other Outcomes (5)

• Incidence of all-cause mortality within 90 days after randomization.

  within 90 days after randomization.

• Incidence of symptomatic intracranial hemorrhage (sICH, per Heidelberg Bleeding Classification) at 24±12 hours from onset.

  at 24±12 hours from onset.

• Incidence of early neurological deterioration

  defined as a NIHSS increase ≥ 10 points at day 7 (±1) or discharge (whichever is earlier). Death within 7 days of onset is directly judged as neurological deterioration.

Study Arms (2)

EVT group

EXPERIMENTAL

Procedure: Patients assigned to the EVT group should undergo EVT as soon as possible, followed by BMM according to the current EVT guidelines.

Medical group

ACTIVE COMPARATOR

Drug: The medical group receives BMM alone. EVT is not performed in the medical group.

Interventions

Patients assigned to the EVT group should undergo EVT as soon as possible, followed by BMM according to the current EVT guidelines. PROCEDURE

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.

EVT group

The medical group receives BMM alone. EVT is not performed in the medical group. DRUG

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.

Medical group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years.
• Symptoms onset or Time last known well ≤ 24 h from randomization.
• 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.
• NCCT or diffusion-weighted imaging (DWI) demonstrating ASPECTS ≤ 2 or infarct core volume (defined as rCBF \<30% on CTP) ≥ 100 mL.
• Selection imaging performed ≤ 3 hours before randomization.
• Pre-stroke mRS 0 - 1.
• Informed consent form was signed.

You may not qualify if:

• Evidence of intracranial hemorrhage on CT/MRI, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, or subdural/epidural hemorrhage.
• Cerebral midline shift or herniation, or other ventricular mass effect with midline shift as confirmed on CT/MRI.
• Bilateral anterior circulation or acute multi-vessel occlusion involving both anterior and posterior circulation, confirmed by CTA or MRA.
• Blood pressure \>185/110 mmHg and is refractory to medicine.
• Known coagulopathy, with international normalized ratio (INR) \>1.7 or platelet count \<100×10⁹/L;
• Current treatment with direct thrombin inhibitors or factor Xa inhibitors;
• Patients with severe organ failure (cardiac, pulmonary, renal, or hepatic);
• Concomitant malignancy or other conditions with life expectancy under 6 months;
• Female who is known to be pregnant;
• Prior endovascular attempt for this stroke;;
• Currently participation in another clinical study;
• Other circumstances that the investigator considers inappropriate for participation.

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

he First Affiliated Hospital of Harbin Medical University

Harbin, Hei Longjiang, 150001, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Huaizhang Shi, MD, PhD

  The First Affiliated Hospital of Harbin Medical University, China

  PRINCIPAL INVESTIGATOR

• Wei Hu, MD, PhD

  The First Affiliated Hospital of USTC (Anhui Provincial Hospital), China

  PRINCIPAL INVESTIGATOR

• Jianmin Liu, MD, PhD

  Changhai Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guang Zhang, MD, PhD

CONTACT

+86 451 85555099; zhangguang@hrbmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 18, 2026
• Primary Completion (Estimated): April 18, 2028
• Study Completion (Estimated): April 18, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data sharing will be available from 12 months after the publication of the main results.
• Access Criteria: 1. The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered. 2. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. 3. Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research. 4. Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection. 5. The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.

Locations

CN (1)