Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy

Eligibility Criteria

• 1. Signs and symptoms consistent with an acute anterior circulation ischemic stroke and associated brain imaging
• 2. Baseline NIHSSS is ≥10 and remains ≥10 immediately prior to randomization
• 3. Treatment can be initiated within 24 hours of stroke onset or time last known well and within 120 minutes of completion of qualifying imaging
• 4. Functionally independent prior to stroke onset
• 5. Patient/ Legally Authorized Representative has signed the Informed Consent form.
• 1. Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months.
• 2. Pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations
• 3. Pregnant
• 4. Unable to undergo a contrast brain perfusion scan with either MRI or CT
• 5. Known allergy to iodine that precludes an endovascular procedure
• 6. Treated with tPA or TNK \>4.5 hours after time last known well
• 7. Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
• 8. Baseline blood glucose of \<50mg/dL (2.78 mmol) or \>400mg/dL (22.20 mmol)
• 9. Baseline platelet count \< 50,000/uL
• 10. Severe, sustained hypertension (SBP \>185 mmHg or DBP \>110 mmHg)
• 11. Current participation in another investigational drug or device study
• 12. Presumed septic embolus; suspicion of bacterial endocarditis
• 13. Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.
• 1. Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation
• 2. Significant mass effect with midline shift
• 3. Evidence of internal carotid artery dissection that is flow limiting or aortic dissection
• 4. Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device
• 5. Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).