Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo

General Inclusion Criteria:

• Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups:
• Subject has failed IV t-PA therapy (defined as a confirmed persistent occlusion 60 min after administration)
• Subject is contraindicated for IV t-PA administration
• Age ≥18
• Baseline NIHSS ≥10 (assessed within one hour of measuring core infarct volume)
• Subject can be randomized between with 6 to 24 hours after time last known well
• No significant pre-stroke disability (pre-stroke mRS must be 0 or 1)
• Anticipated life expectancy of at least 6 months
• Subject willing/able to return for protocol required follow up visits
• Subject or subject's Legally Authorized Representative (LAR) has signed the study Informed Consent form*
• If approved by local ethics committee and country regulations, the investigator is allowed to enroll a patient utilizing emergency informed consent procedures if neither the patient nor the representative or person of trust is available to sign the informed consent form. However, as soon as possible, the patient is informed and his/her consent is requested for the possible continuation of this research. (Not applicable to U.S. Sites.)

Imaging Inclusion Criteria:

• 400mg/dL (22.20 mmol)
• Baseline hemoglobin counts of 6 mEq/L
• Renal failure as defined by a serum creatinine >3.0 mg/dL (264 µmol/L) NOTE: subjects on renal dialysis may be treated regardless of serum creatinine levels
• Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with INR > 3.0 or PTT > 3 times normal. Patients on factor Xa inhibitor for 24-48 hours ago must have a normal PTT.
• Any active or recent hemorrhage within the past 30 days
• History of severe allergy (more than rash) to contrast medium
• Severe, sustained hypertension (Systolic Blood Pressure >185 mmHg or Diastolic Blood Pressure >110 mmHg) NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using medication the subject can be enrolled
• Female who is pregnant or lactating at time of admission
• Current participation in another investigational drug or device study
• Presumed septic embolus, or suspicion of bacterial endocarditis
• Treatment with any cleared thrombectomy devices or other intra-arterial (neurovascular) therapies prior to randomization

Imaging Exclusion Criteria:

• Evidence of intracranial hemorrhage on CT/MRI
• CTA or MRA evidence of flow limiting carotid dissection, high-grade stenosis, or complete cervical carotid occlusion requiring stenting at the time of the index procedure (i.e., mechanical thrombectomy).
• Excessive tortuosity of cervical vessels on CTA/MRA that would likely preclude device delivery/deployment
• Suspected cerebral vasculitis based on medical history and CTA/MRA
• Suspected aortic dissection based on medical history and CTA/MRA
• Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the Trevo device
• Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior circulation/vertebrobasilar system) as confirmed on CTA/MRA, or clinical evidence of bilateral strokes or strokes in multiple territories
• Significant mass effect with midline shift as confirmed on CT/MRI
• Evidence of intracranial tumor (except small meningioma) as confirmed on CT/MRI