Status:
RECRUITING
Large Artery Occlusion Treated in Extended Time with Mechanical Thrombectomy Trial
Lead Sponsor:
The George Institute for Global Health, China
Collaborating Sponsors:
Changhai Hospital
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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
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 outcom...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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 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.
- Neuroimaging Exclusion Criteria
- Intracranial hemorrhage (ICH), including parenchymal hemorrhage, ventricular hemorrhage, subarachnoid hemorrhage, and subdural/exsanguination
- Evidence of intracranial tumor (except small meningioma)
- 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)
Key Trial Info
Start Date :
November 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
382 Patients enrolled
Trial Details
Trial ID
NCT05326932
Start Date
November 3 2022
End Date
December 31 2025
Last Update
March 26 2025
Active Locations (1)
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1
Changhai Hospital
Shanghai, China