Large Artery Occlusion Treated in Extended Time With Mechanical Thrombectomy Trial
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
The George Institute for Global Health, China
382 participants
Nov 3, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria22
- 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.
- 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)
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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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05326932