Acute Ischemic StrokeLATE-MTNCT05326932
Large Artery Occlusion Treated in Extended Time With Mechanical Thrombectomy Trial
A study testing Mechanical thrombectomy in people with Acute Ischemic Stroke, run by Lili SONG at 1 site in China.
Trial summary
A multi-center, prospective, randomized, open-label, adaptive group sequential designed, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Mechanical thrombectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2022to 17 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age ≥18 years
- Present 24-72 hours of stroke onset or last seen well
- Clinical diagnosis of AIS due to anterior circulation LVO (from internal carotid artery (ICA) extracranial segment to middle cerebral artery (MCA) M1 and M2 segment) on brain imaging
- National Institute of Health stroke scale (NIHSS) ≥6 at randomisation
- Viable cerebral tissue on computerized tomography perfusion (CTP) assessed: infarct core volume <50 mL, mismatch ratio ≥1.8, and mismatch volume ≥15 mL
- Written informed consent (by patient or proxy, according to local requirements)
Who cannot join
- Clinical Exclusion Criteria
- Considered unlikely to benefit from trial (e.g. advanced dementia, major pre-stroke disability (prior modified Rankins scale (mRS) ≥2), high likelihood of early death), as judged by the responsible treating clinician
- Major co-morbid disease that could interfere with outcome assessments and follow-up (e.g. cancer, severe heart failure, kidney failure)
- Pregnancy
- Unable to undergo a CTP
- Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure
Show all 24Show fewer
- Seizures at stroke onset or before randomization and baseline NIHSS scores cannot be accurately determined
- Baseline blood glucose of <50 mg/dL (2.78 mmol/L) or >400 mg/dL (22.20 mmol/L)
- Baseline platelet count < 50,000/uL
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with International normalized ratio (INR) >3
- Severe, sustained hypertension that can not be controlled by medication (systolic BP >220 mmHg or diastolic BP >120 mmHg)
- Presumed septic embolus, suspicion of bacterial endocarditis
- EVT attempted after stroke onset
- Unlikely to participate in follow-up assessments
- Currently participating in another trial that may affect outcomes.
- Any other condition that, in the opinion of the investigator will pose a significant hazard to the subject if participating in the trial.
- Neuroimaging Exclusion Criteria
- Intracranial hemorrhage (ICH), including parenchymal hemorrhage, ventricular hemorrhage, subarachnoid hemorrhage, and subdural/exsanguination
- Evidence of intracranial malignant tumor
- Significant mass effect with midline shift
- Aortic dissection
- Intracranial stent implanted in the same vascular territory
- Any other condition that may affect EVT procedure, like the tortuous vascular path the device is difficult to reach the target position or difficult to recover
- Occlusions in multiple vascular territories confirmed on Computerized tomography angiography (CTA)/ Magnetic resonance imaging angiography (MRA) (e.g. bilateral MCA occlusions, or an MCA and a basilar artery occlusion)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigator Initiated and Conducted, Prospective, Multicenter, Randomized Outcome-blinded Study of Treating Mechanical Thrombectomy Exceeding 24 Hours in Patients With Acute Ischemic Stroke Due to Large Vessel Occlusion
A multi-center, prospective, randomized, open-label, adaptive group sequential designed, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS
Read the detailed description
The LATE-MT trial aims to determine that compared with standard medical care without MT, performing MT in a time window that exceeds 24 hours after last seen well, is superior on the functional outcome in AIS patients due to LVO who have been carefully selected by clinical and imaging criteria. The secondary aims include comparing with standard medical care without MT, to determine whether performing MT exceeding 24 hours of last known well is safe on the risks of any ICH, sICH, and any SAE. Other secondary aims include early improvement in neurological recovery as measured by NIHSS scores at 7 days; successful recanalization rate; imaging measurements of infarct size; death or major disability (mRS 3-6); separately on death and disability (mRS 3-5); HRQoL using Euro-QoL EQ-5D questionnaire; utility-weighted modified Rankin scale scores; duration of hospitalization; Barthel Index; and hospital service costs.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Mechanical thrombectomy
- Keywords
- Acute ischemic stroke, Large vessel occlusion, Mechanical thrombectomy, Extended time, Randomised clinical trial
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical thrombectomyProcedure or surgery
Subjects in intervention group will receive MT as soon as possible. Investigators and clinicians should strive to reduce delays of pre-surgery procedure and follow the local standard guideline of MT during the operation and perioperative period. All CFDA approved devices are allowed in this trial. Angioplasty and stent placement can be performed at the discretion of the physicians. Base on site experience, the randomization-operation start period should be within 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Mechanical thrombectomy to be initiated as soon as possible after randomisation. Receives: Procedure: Mechanical thrombectomy |
| Control group | No intervention | Patients assigned to the control group will avoid treating MT and only receive the standard medical treatment according to local guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional recovery (level of disability)
A sequence shift (improvement) in scores on the modified Rankin scale (mRS). The value range 0-6: higher scores mean a worse outcome.
Measured: at 90 days
Secondary outcomes (9)
Neurological function
Measured by scores on the National Institute of Health Stroke Scale (NIHSS). The value range 0-42: higher scores mean a worse outcome.
Measured: at 24 hours and 7 days
Death or major disability
mRS 3-6
Measured: at 90 days
Major disability
mRS 3-5
Measured: at 90 days
Death
Death from any cause
Measured: within 90 days
Utility-weighted modified Rankin scale scores
Utility-weighted mRS scores calculated by utility weights. A higher score indicates a better outcome
Measured: at 90 days
Health-related Quality of Life (HRQoL)
Using the EuroQol 5 Dimension 5 Level (EQ 5D 5L) questionnaire. The EQ 5D 5L comprises five dimensions of health: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five severity levels (no problems, slight problems, moderate problems, severe problems, and extreme problems)
Measured: at 90 days
Barthel Index
The total score ranges from 0 to 100, with higher scores indicating greater independence in self care
Measured: at 90 days
Infarct volume
Measured on follow-up CT/MRI
Measured: at 7 days
Recanalization
Assessed by CTA/MRA
Measured: at 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start3 Nov 2022
- Primary completion17 Mar 2026
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies 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
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lili SONG
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, Fudan University
- Responsible party
- Sponsor-investigator, Lili SONG, Fudan University
- Investigators
- Craig Anderson, PhD, Principal investigator, The George Institute for Global Health, ChinaJianmin Liu, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326932
- Sponsor's protocol ID
- LATE-MT
- Acronym
- LATE-MT
- Status last verified
- Sep 2026
- First submitted
- 29 Mar 2022
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared with bona fide researchers after one year of the publication of the main results, based on a submitted protocol to the steering committee of LATE-MT.
Publications
Yang P, Shen H, Yi T, Xing P, Su J, Wen C, Zhong W, Li Q, He Y, Chen X, He S, Ren X, You S, Zhao Y, Wang B, Zhang Y, Chen L, Zhu X, Zhang M, Yu Y, Jiang Y, Wu Y, Wang C, Zhang X, Yang W, Shen F, Wang L, Huyan M, Tian B, Chen W, Nan G, Zhang L, Shi H, Han J, Li T, Zhang F, Wei M, Xu C, Peng Y, Sun J, Wang S, Han H, Wang H, Cai W, Zhang M, Yin C, Cheng G, Yin R, Zhang Q, Xiao G, Zhang Y, Liu S, Li H, Zhang L, Li Z, Zhou Y, Zhao R, Li Q, Majoie CBLM, Song L, Zhang Y, Anderson CS, Liu J; LATE-MT Investigators. Mechanical Thrombectomy 24 to 72 Hours after Large-Vessel Ischemic Stroke. N Engl J Med. 2026 Oct 23. doi: 10.1056/NEJMoa2609362. Online ahead of print.
PubMed 42929656
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Initiated and Conducted, Prospective, Multicenter, Randomized Outcome-blinded Study of Treating Mechanical Thrombectomy Exceeding 24 Hours in Patients With Acute Ischemic Stroke Due to Large Vessel Occlusion
- ClinicalTrials.gov ID
- NCT05326932
- Acronym / sponsor ID
- LATE-MT / LATE-MT
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute ischemic stroke, Large vessel occlusion, Mechanical thrombectomy, Extended time, Randomised clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Lili SONGUniversity, hospital or other
- Collaborators
- Changhai Hospital, Fudan University
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 14 Apr 2022 (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.
A multi-center, prospective, randomized, open-label, adaptive group sequential designed, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS
Detailed description
The LATE-MT trial aims to determine that compared with standard medical care without MT, performing MT in a time window that exceeds 24 hours after last seen well, is superior on the functional outcome in AIS patients due to LVO who have been carefully selected by clinical and imaging criteria. The secondary aims include comparing with standard medical care without MT, to determine whether performing MT exceeding 24 hours of last known well is safe on the risks of any ICH, sICH, and any SAE. Other secondary aims include early improvement in neurological recovery as measured by NIHSS scores at 7 days; successful recanalization rate; imaging measurements of infarct size; death or major disability (mRS 3-6); separately on death and disability (mRS 3-5); HRQoL using Euro-QoL EQ-5D questionnaire; utility-weighted modified Rankin scale scores; duration of hospitalization; Barthel Index; and hospital service costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Mechanical thrombectomyMechanical thrombectomy to be initiated as soon as possible after randomisation. |
| Control group | No intervention | –Patients assigned to the control group will avoid treating MT and only receive the standard medical treatment according to local guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Present 24-72 hours of stroke onset or last seen well
- Clinical diagnosis of AIS due to anterior circulation LVO (from internal carotid artery (ICA) extracranial segment to middle cerebral artery (MCA) M1 and M2 segment) on brain imaging
- National Institute of Health stroke scale (NIHSS) ≥6 at randomisation
- Viable cerebral tissue on computerized tomography perfusion (CTP) assessed: infarct core volume <50 mL, mismatch ratio ≥1.8, and mismatch volume ≥15 mL
Key exclusion criteria (24 listed)
- Clinical Exclusion Criteria
- Considered unlikely to benefit from trial (e.g. advanced dementia, major pre-stroke disability (prior modified Rankins scale (mRS) ≥2), high likelihood of early death), as judged by the responsible treating clinician
- Major co-morbid disease that could interfere with outcome assessments and follow-up (e.g. cancer, severe heart failure, kidney failure)
- Pregnancy
- Unable to undergo a CTP
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 |
|---|---|---|
| Mechanical thrombectomySubjects in intervention group will receive MT as soon as possible. Investigators and clinicians should strive to reduce delays of pre-surgery procedure and follow the local standard guideline of MT during the operation and perioperative period. All CFDA approved devices are allowed in this trial. Angioplasty and stent placement can be performed at the discretion of the physicians. Base on site experience, the randomization-operation start period should be within 60 minutes. | Procedure or surgery | Intervention group |
Primary outcome
Functional recovery (level of disability)
Time frame: at 90 days
A sequence shift (improvement) in scores on the modified Rankin scale (mRS). The value range 0-6: higher scores mean a worse outcome.
9 secondary outcomes
Neurological function
Time frame: at 24 hours and 7 days
Death or major disability
Time frame: at 90 days
Major disability
Time frame: at 90 days
Death
Time frame: within 90 days
Utility-weighted modified Rankin scale scores
Time frame: at 90 days
Health-related Quality of Life (HRQoL)
Time frame: at 90 days
Barthel Index
Time frame: at 90 days
Infarct volume
Time frame: at 7 days
Recanalization
Time frame: at 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Derived from this study: PubMed 42929656Yang P, Shen H, Yi T, Xing P, Su J, Wen C, Zhong W, Li Q, He Y, Chen X, He S, Ren X, You S, Zhao Y, Wang B, Zhang Y, Chen L, Zhu X, Zhang M, Yu Y, Jiang Y, Wu Y, Wang C, Zhang X, Yang W, Shen F, Wang L, Huyan M, Tian B, Chen W, Nan G, Zhang L, Shi H, Han J, Li T, Zhang F, Wei M, Xu C, Peng Y, Sun J, Wang S, Han H, Wang H, Cai W, Zhang M, Yin C, Cheng G, Yin R, Zhang Q, Xiao G, Zhang Y, Liu S, Li H, Zhang L, Li Z, Zhou Y, Zhao R, Li Q, Majoie CBLM, Song L, Zhang Y, Anderson CS, Liu J; LATE-MT Investigators. Mechanical Thrombectomy 24 to 72 Hours after Large-Vessel Ischemic Stroke. N Engl J Med. 2026 Oct 23. doi: 10.1056/NEJMoa2609362. Online ahead of print.
- Individual participant dataSharing planned: Yes. Data can be shared with bona fide researchers after one year of the publication of the main results, based on a submitted protocol to the steering committee of LATE-MT.
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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. This study is not recruiting at the moment.
Craig Anderson, PhD principal investigator
The George Institute for Global Health, China
Jianmin Liu principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical thrombectomy in people with Acute Ischemic Stroke, run by Lili SONG 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 6 inclusion and 24 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: finished, as of the sponsor's last update on 23 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional recovery (level of disability) (time frame: at 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05326932, which also lists 1 linked publication.
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 23 Sep 2026.