Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy

Korábbi kezelés

• Treated with tPA or TNK >4.5 hours after time last known well
• Current participation in another investigational drug or device study

Más betegség

• Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months.
• Pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations
• Known allergy to iodine that precludes an endovascular procedure
• Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
• Severe, sustained hypertension (SBP >185 mmHg or DBP >110 mmHg)
• 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.
  • NEUROIMAGING Exclusion:
• Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation

Laborértékek

• Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol)
• Baseline platelet count < 50,000/uL

Egyéb

• Pregnant
• Unable to undergo a contrast brain perfusion scan with either MRI or CT
• Presumed septic embolus; suspicion of bacterial endocarditis
• Significant mass effect with midline shift
• Evidence of internal carotid artery dissection that is flow limiting or aortic dissection
• Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device
• 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).

• Signs and symptoms consistent with an acute anterior circulation ischemic stroke and associated brain imaging
• Baseline NIHSSS is ≥10 and remains ≥10 immediately prior to randomization
• Treatment can be initiated within 24 hours of stroke onset or time last known well and within 120 minutes of completion of qualifying imaging
• Functionally independent prior to stroke onset
• Patient/ Legally Authorized Representative has signed the Informed Consent form.