AISLARGE CORE-MTNCT07791810
Endovascular Treatment for Acute Large Vessel Occlusion With Ultra-Large Ischemic Core
A study testing Patients assigned to the EVT group should undergo EVT as soon as possible, followed by BMM according to the current EVT guidelines. and The medical group receives BMM alone. EVT is not performed in the medical group. in people with AIS and Stroke, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
an investigator initiated, prospective, multicenter, randomized, open-label, blinded endpoint trial (PROBE) Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Patients assigned to the EVT group should undergo EVT as soon as possible, followed by BMM according to the current EVT guidelines. and The medical group receives BMM alone. EVT is not performed in the medical group.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2026to 18 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
he First Affiliated Hospital of Harbin Medical University
Harbin, Hei Longjiang, 150001
Guang Zhang, M.D., Ph.D., +86 451 85555099, zhangguang@hrbmu.edu.cn
Huaizhang SHi, M.D., Ph.D.
About this study
Official title: Endovascular Treatment for Acute Large Vessel Occlusion With Ultra-Large Ischemic Core: A Prospective, Multicenter, Randomized, Open-label, Blinded Endpoint Trial (LARGE CORE-MT)
an investigator initiated, prospective, multicenter, randomized, open-label, blinded endpoint trial (PROBE)
Read the detailed description
The primary objective is to determine whether EVT combined with BMM, compared with BMM alone, improves functional outcome in patients with intracranial LVO in anterior circulation and ultra large-core treated within 24 hours of symptom onset.
Primary Efficacy Endpoint Analysis The primary efficacy endpoint is the mRS score at 90 days after randomization. The proportional odds assumption will be formally assessed. If this assumption holds (score test p-value > 0.05), the primary effect measure is the common odds ratio (cOR), which will be estimated using an ordinal logistic regression model to assess the shift in the overall distribution of the mRS scale at 90 days. The model will be adjusted for known prognostic factors including baseline ASPECTS score, age, NIHSS score at admission, and intravenous thrombolysis, as well as the randomization stratification factor, i.e., time from stroke onset or last known well to randomization (≤6 hours vs. >6 hours). Unadjusted cOR estimates and confidence intervals (CI) will also be reported. If the assumption is violated, the generalized odds ratio (GenOR) and its 95% CI will be derived as a robust alternative measure of treatment effect.
Secondary Efficacy Endpoints Analysis For the secondary endpoint of mRS score at 180 days after randomization, the same analysis method as for the primary endpoint will be used. For the proportions of mRS 0-2 and mRS 0-3 at 90 days and 180 days, early neurological improvement, a modified Poisson regression model will be used, reporting Risk Ratio and 95% CI, with the same adjustment factors as in the primary endpoint analysis. For the comparison of EQ-5D-5L score at 90 days between two arms, a linear regression model will be used to estimate the mean difference and 95% CI. For the change in infarct volume from baseline assessed by NCCT at 7 (±1) days or discharge (whichever occurs earlier), or by MRI at 36 (±12) hours after randomization, a linear regression model will be used to estimate the mean difference and 95% CI, with treatment group as the study variable and baseline measurement as a covariate; if normality assumptions are violated, the win ratio method will be used.
Safety Analysis For the primary safety endpoint of all-cause mortality within 90 days after randomization, the Chi-squared test or Fisher's exact test will be used for between-group comparison. For the secondary safety endpoints, including incidence of sICH within 24 hours from onset, proportion of early neurological deterioration, procedure- or device-related complications, and serious adverse events adjudicated by the Clinical Events Committee, data summary will be performed by treatment group.
- Being tested
- 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.
- Keywords
- LARGE CORE-MT, AIS, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients assigned to the EVT group should undergo EVT as soon as possible, followed by BMM according to the current EVT guidelines.Procedure or surgery
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.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.
| Study group | Role | What they receive |
|---|---|---|
| EVT group | Experimental | Not described Receives: 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 | Not described Receives: Drug: The medical group receives BMM alone. EVT is not performed in the medical group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the mRS score at 90 days after randomization.
Measured: at 90 days after randomization.
Secondary outcomes (6)
mRS score at 180 days after randomization.
Measured: at 180 days after randomization.
Proportion of mRS 0-2 at 90 days and 180 days after randomization.
Measured: at 90 days and 180 days after randomization.
Proportion of mRS 0-3 at 90 days and 180 days after randomization.
Measured: at 90 days and 180 days after randomization.
Proportion of early neurological improvement
Measured: 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.
Measured: at 7 (±1) days after randomization or discharge (whichever is earlier), or by MRI at 36 (±12) hours.
EQ-5D-5L score at 90 days.
Measured: at 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start18 Sep 2026 (estimated)
- Primary completion18 Apr 2028 (estimated)
- Study completion18 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huaizhang Shi, MD, PhD, Principal investigator, The First Affiliated Hospital of Harbin Medical University, ChinaWei Hu, MD, PhD, Principal investigator, The First Affiliated Hospital of USTC (Anhui Provincial Hospital), ChinaJianmin Liu, MD, PhD, Principal investigator, Changhai Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791810
- Sponsor's protocol ID
- LARGE CORE-MT
- Acronym
- LARGE CORE-MT
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data may be shared with bona fide researchers following publication of the main results, upon receipt of a protocol submitted to the LARGE CORE-MT Steering Committee.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Treatment for Acute Large Vessel Occlusion With Ultra-Large Ischemic Core: A Prospective, Multicenter, Randomized, Open-label, Blinded Endpoint Trial (LARGE CORE-MT)
- ClinicalTrials.gov ID
- NCT07791810
- Acronym / sponsor ID
- LARGE CORE-MT / LARGE CORE-MT
- Keywords
- LARGE CORE-MT, AIS, stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 18 Sep 2026 (estimated)
- Primary completion
- 18 Apr 2028 (estimated)
- Study completion
- 18 Apr 2028 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
an investigator initiated, prospective, multicenter, randomized, open-label, blinded endpoint trial (PROBE)
Detailed description
The primary objective is to determine whether EVT combined with BMM, compared with BMM alone, improves functional outcome in patients with intracranial LVO in anterior circulation and ultra large-core treated within 24 hours of symptom onset.
Primary Efficacy Endpoint Analysis The primary efficacy endpoint is the mRS score at 90 days after randomization. The proportional odds assumption will be formally assessed. If this assumption holds (score test p-value > 0.05), the primary effect measure is the common odds ratio (cOR), which will be estimated using an ordinal logistic regression model to assess the shift in the overall distribution of the mRS scale at 90 days. The model will be adjusted for known prognostic factors including baseline ASPECTS score, age, NIHSS score at admission, and intravenous thrombolysis, as well as the randomization stratification factor, i.e., time from stroke onset or last known well to randomization (≤6 hours vs. >6 hours). Unadjusted cOR estimates and confidence intervals (CI) will also be reported. If the assumption is violated, the generalized odds ratio (GenOR) and its 95% CI will be derived as a robust alternative measure of treatment effect.
Secondary Efficacy Endpoints Analysis For the secondary endpoint of mRS score at 180 days after randomization, the same analysis method as for the primary endpoint will be used. For the proportions of mRS 0-2 and mRS 0-3 at 90 days and 180 days, early neurological improvement, a modified Poisson regression model will be used, reporting Risk Ratio and 95% CI, with the same adjustment factors as in the primary endpoint analysis. For the comparison of EQ-5D-5L score at 90 days between two arms, a linear regression model will be used to estimate the mean difference and 95% CI. For the change in infarct volume from baseline assessed by NCCT at 7 (±1) days or discharge (whichever occurs earlier), or by MRI at 36 (±12) hours after randomization, a linear regression model will be used to estimate the mean difference and 95% CI, with treatment group as the study variable and baseline measurement as a covariate; if normality assumptions are violated, the win ratio method will be used.
Safety Analysis For the primary safety endpoint of all-cause mortality within 90 days after randomization, the Chi-squared test or Fisher's exact test will be used for between-group comparison. For the secondary safety endpoints, including incidence of sICH within 24 hours from onset, proportion of early neurological deterioration, procedure- or device-related complications, and serious adverse events adjudicated by the Clinical Events Committee, data summary will be performed by treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | EVT group |
| 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. | Drug | Medical group |
Primary outcome
The primary efficacy endpoint is the mRS score at 90 days after randomization.
Time frame: at 90 days after randomization.
6 secondary outcomes
mRS score at 180 days after randomization.
Time frame: at 180 days after randomization.
Proportion of mRS 0-2 at 90 days and 180 days after randomization.
Time frame: at 90 days and 180 days after randomization.
Proportion of mRS 0-3 at 90 days and 180 days after randomization.
Time frame: at 90 days and 180 days after randomization.
Proportion of early neurological improvement
Time frame: 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.
Time frame: at 7 (±1) days after randomization or discharge (whichever is earlier), or by MRI at 36 (±12) hours.
EQ-5D-5L score at 90 days.
Time frame: at 90 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Yes. Data may be shared with bona fide researchers following publication of the main results, upon receipt of a protocol submitted to the LARGE CORE-MT Steering Committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huaizhang Shi, MD, PhD principal investigator
The First Affiliated Hospital of Harbin Medical University, China
Wei Hu, MD, PhD principal investigator
The First Affiliated Hospital of USTC (Anhui Provincial Hospital), China
Jianmin Liu, MD, PhD principal investigator
Changhai Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients assigned to the EVT group should undergo EVT as soon as possible, followed by BMM according to the current EVT guidelines. and The medical group receives BMM alone. EVT is not performed in the medical group. in people with AIS and Stroke, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guang Zhang, MD, PhD (+86 451 85555099, zhangguang@hrbmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy endpoint is the mRS score at 90 days after randomization. (time frame: at 90 days after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.