DAWN Trial: Thrombectomy for Ischemic Stroke (6-24 Hours)

General Inclusion Criteria

• ✓Clinical signs and symptoms consistent with the diagnosis of acute ischemic stroke, and subject belongs to one of the following two categories: failed IV t-PA therapy (defined as a confirmed persistent occlusion 60 minutes post IV t-PA administration) OR contraindicated for IV t-PA administration
• ✓Age ≥18
• ✓Baseline NIHSS ≥10 (assessed within one hour of measuring the core infarct volume)
• ✓Randomization can be initiated between 6 to 24 hours after time last known well
• ✓No significant pre-stroke disability (pre-stroke mRS 0 to 1)
• ✓Anticipated life expectancy of at least 6 months
• ✓Subject is willing and able to return for protocol-required follow-up visits
• ✓Subject or subject's Legally Authorized Representative has signed and dated an Informed Consent Form

Imaging Inclusion Criteria

• ✓<1/3 MCA territory involved, as evidenced by CT or MRI
• ✓Occlusion of the intracranial internal carotid artery and/or the MCA-M1 segment, as evidenced by MRA or CTA
• ✓Clinical Imaging Mismatch (CIM), defined as one of: (Group A) age ≥80 years, NIHSS ≥10, and core infarct 0 to <21 cc; (Group B) age <80 years, NIHSS ≥10, and core infarct 0 to <31 cc; (Group C) age <80 years, NIHSS ≥20, and core infarct 31 to <51 cc

General Exclusion Criteria

• ✕Severe head injury within the past 90 days with residual neurological deficit
• ✕Rapid neurological improvement to a NIHSS <10 or evidence of vessel recanalization prior to randomization
• ✕Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g., dementia requiring an anti-cholinesterase inhibitor)
• ✕Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS assessment, and the diagnosis is in doubt
• ✕Baseline blood glucose <50 mg/dL (2.78 mmol) or >400 mg/dL (22.20 mmol)
• ✕Baseline hemoglobin <7 mmol/L
• ✕Baseline platelet count <50,000/µL
• ✕Abnormal baseline electrolytes: sodium <130 mmol/L, potassium <3 or >6 mEq/L
• ✕Renal failure: serum creatinine >3.0 mg/dL (264 µmol/L) (patients on dialysis are exempt)
• ✕Known hemorrhagic diathesis, coagulation factor deficiency, or anticoagulant therapy with INR >3.0 or PTT >3 times normal; recent use of a Factor Xa inhibitor within 24-48 hours requires a normal PTT
• ✕Active or recent hemorrhage within the past 30 days
• ✕Severe allergy (more than rash) to contrast medium
• ✕Severe, sustained hypertension: systolic BP >185 mmHg or diastolic BP >110 mmHg (patients are eligible if BP can be reduced with medication)
• ✕Pregnant or lactating females
• ✕Current participation in another investigational drug or device study
• ✕Presumed septic embolus or suspected bacterial endocarditis
• ✕Prior treatment with cleared thrombectomy devices or intra-arterial neurovascular therapies

Imaging Exclusion Criteria

• ✕Evidence of intracranial hemorrhage on CT or MRI
• ✕CTA or MRA evidence of a flow-limiting carotid dissection, high-grade stenosis, or complete cervical carotid occlusion requiring stenting
• ✕Excessive cervical vessel tortuosity that precludes device delivery/deployment
• ✕Suspected cerebral vasculitis based on medical history and imaging
• ✕Suspected aortic dissection based on medical history and imaging
• ✕Intracranial stent in the same vascular territory that precludes safe deployment/removal of the Trevo device
• ✕Occlusions in multiple vascular territories or clinical evidence of bilateral or multi-territorial strokes
• ✕Significant mass effect with midline shift on CT or MRI
• ✕Evidence of intracranial tumor (except small meningioma) on CT or MRI