Large Artery Occlusion Treated in Extended Time with Mechanical Thrombectomy Trial

Last updated: March 22, 2025
Sponsor: The George Institute for Global Health, China
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Thrombosis

Cerebral Ischemia

Treatment

Mechanical thrombectomy

Clinical Study ID

NCT05326932
LATE-MT
  • Ages > 18
  • All Genders

Study Summary

A multi-center, prospective, randomized, open-label, adaptive group sequential designed, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years

  2. Present 24-72 hours of stroke onset or last seen well

  3. Clinical diagnosis of AIS due to anterior circulation LVO (from internal carotidartery (ICA) extracranial segment to middle cerebral artery (MCA) M1 and M2 segment)on brain imaging

  4. National Institute of Health stroke scale (NIHSS) ≥6 at randomisation

  5. Viable cerebral tissue on computerized tomography perfusion (CTP) or magneticresonance imaging perfusion (MRP) assessed: infarct core volume <50mL, mismatchratio ≥1.8 and mismatch volume ≥15mL

  6. Written informed consent (by patient or proxy, according to local requirements)

Exclusion

Exclusion Criteria:

Clinical Exclusion Criteria

  1. Considered unlikely to benefit from trial (e.g. advanced dementia, major pre-strokedisability (prior modified Rankins scale (mRS) ≥2), high likelihood of early death),as judged by the responsible treating clinician

  2. Major co-morbid disease that could interfere with outcome assessments and follow-up (e.g. cancer, severe heart failure, kidney failure)

  3. Pregnancy

  4. Unable to undergo a CTP or MRP

  5. Known allergy to iodine, heparin, anaesthesia, or other definite contraindication toreceiving endovascular treatment (EVT) procedure

  6. Seizures at stroke onset or before randomization and baseline NIHSS scores cannot beaccurately determined

  7. Baseline blood glucose of <50mg/dL (2.78 mmol/L) or >400mg/dL (22.20 mmol/L)

  8. Baseline platelet count <50,000/uL

  9. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency;recent oral anticoagulant therapy with International normalized ratio (INR) >3

  10. Severe, sustained hypertension (systolic blood pressure (BP) >220 mmHg or diastolicBP >120 mmHg)

  11. Presumed septic embolus, suspicion of bacterial endocarditis

  12. EVT attempted after stroke onset

  13. Unlikely to participate in follow-up assessments

  14. Currently participating in another trial that may affect outcomes.

  15. Any other condition that, in the opinion of the investigator will pose a significanthazard to the subject if participating in the trial.

Neuroimaging Exclusion Criteria

  1. Intracranial hemorrhage (ICH), including parenchymal hemorrhage, ventricularhemorrhage, subarachnoid hemorrhage, and subdural/exsanguination

  2. Evidence of intracranial tumor (except small meningioma)

  3. Significant mass effect with midline shift

  4. Aortic dissection

  5. Intracranial stent implanted in the same vascular territory

  6. Any other condition that may affect EVT procedure, like the tortuous vascular paththe device is difficult to reach the target position or difficult to recover

  7. Occlusions in multiple vascular territories confirmed on Computerized tomographyangiography (CTA)/ Magnetic resonance imaging angiography (MRA) (e.g. bilateral MCAocclusions, or an MCA and a basilar artery occlusion)

Study Design

Total Participants: 382
Treatment Group(s): 1
Primary Treatment: Mechanical thrombectomy
Phase:
Study Start date:
November 03, 2022
Estimated Completion Date:
December 31, 2025

Study 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 at 24-48 hours; 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; residence; and hospital service costs.

Connect with a study center

  • Changhai Hospital

    Shanghai,
    China

    Active - Recruiting

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