Large Artery Occlusion Treated in Extended Time With Mechanical Thrombectomy Trial
LATE-MT
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
1 other identifier
interventional
382
1 country
1
Brief Summary
A multi-center, prospective, randomized, open-label, adaptive group sequential designed, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2022
CompletedFirst Posted
Study publicly available on registry
April 14, 2022
CompletedStudy Start
First participant enrolled
November 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
ExpectedMarch 6, 2026
March 1, 2026
3.4 years
March 29, 2022
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
90 days
Secondary Outcomes (10)
Neurological function
24±12 hours and 7±1 days
Death or major disability
90 days
Separately on death and disability
90 days
Utility-weighted modified Rankin scale scores
90 days
Health-related Quality of Life (HRQoL)
90 days
- +5 more secondary outcomes
Other Outcomes (3)
Intracerebral hemorrhage (ICH)
24 hours and 90 days
Death
7 days and 90 days
Serious adverse events (SAE)
90 days
Study Arms (2)
Intervention group
EXPERIMENTALMechanical thrombectomy to be initiated as soon as possible after randomisation.
Control group
NO INTERVENTIONPatients assigned to the control group will avoid treating MT and only receive the standard medical treatment according to local guidelines.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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) or magnetic resonance imaging perfusion (MRP) assessed: infarct core volume \<50mL, mismatch ratio ≥1.8 and mismatch volume ≥15mL
- Written informed consent (by patient or proxy, according to local requirements)
You may not qualify if:
- 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 or MRP
- Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure
- Seizures at stroke onset or before randomization and baseline NIHSS scores cannot be accurately determined
- Baseline blood glucose of \<50mg/dL (2.78 mmol/L) or \>400mg/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 (systolic blood pressure (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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The George Institute for Global Health, Chinalead
- Changhai Hospitalcollaborator
Study Sites (1)
Changhai Hospital
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Craig Anderson, PhD
The George Institute for Global Health, China
- PRINCIPAL INVESTIGATOR
Jianmin Liu
Changhai Hospital
Central Study Contacts
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
March 29, 2022
First Posted
April 14, 2022
Study Start
November 3, 2022
Primary Completion
March 31, 2026
Study Completion (Estimated)
March 31, 2028
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- 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.
Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to the research office of The George Institute for Global Health, Sydney Australia.