Patient description: A 62-year-old African-American man presented with left upper and lower extremity weakness, associated with dark visual spot in right eye, right facial numbness, facial drop and slurred speech. He denied dyspnea, headache, palpitations, chest pain, fever, dizziness, bowel or urinary incontinence, loss of consciousness. His medical history was significant for hypertension, hyperlipidemia and hypothyroidism. He smokes cigarette 1 pack per day for 40 years and alcohol consumption of 5 to 6 beers per week. He is not aware about his family history. He is using Levothyroxine, Atorvastatin and HTCZ. His vital signs were stable in the primary evaluation. Left-sided facial droop, dysarthria, and left-sided hemiplegia were seen in the physical exam. His National Institutes of Health Stroke Scale (NIHSS) score was calculated as 7. Initial CT angiogram of head and neck reported no acute intracranial findings. Intravenous recombinant tissue plasminogen activator (t-PA) was administered as well as high-dose statin therapy. The patient was admitted to the intensive care unit to be monitored for 24 hours. MRI of the head revealed an acute 1.7-cm infarct of the right periventricular white matter and posterior right basal ganglia.

Clinical trial eligibility criteria: eligible ages (years): 18.0-80.0,  Acute Ischemic Stroke Subjects with acute ischemic stroke 2. Subjects that initially present at non-EVT treating hospitals that have established transport services in place to transfer subjects to hospitals capable of performing EVT 3. Males or females 18 years of age 4. Subjects presenting within time window for IV tPA treatment approved by local regulatory authorities but no more than 4.5 hours from onset of symptoms 5. No signs of intracranial bleeding on assessment by non-contrast CT 6. Subjects that in the opinion of the treating physician require treatment with full dose of IV tPA (0.9mg/kg) as standard of care per institutional standards 7. SBP ≤ 185 mmHg and DBP ≤ 105 mmHg at baseline or after treatment of hypertension with medications prior to tPA bolus 8. Pre-morbid mRS of 0-1 9. Arterial occlusion in the middle cerebral artery (MCA) M1 or proximal M2, intracranial carotid T, anterior cerebral artery (ACA) A1, basilar, proximal posterior cerebral artery (PCA) P1 or intracranial tandem lesions in these locations visible on CT angiography (CTA) 10. Provision of informed consent as demonstrated by the subject's signature or by the signature of the subject's authorized legal representative on the Informed Consent Form in accordance with all local and national regulations and no later than 15 minutes after standard of care tPA administration  Tandem lesions where one lesion is extracranial (carotid or vertebral artery) 2. score < 6 on non contrast CT or ischemic changes that in the opinion of the investigator would be medically inappropriate for reperfusion therapy 3. Poor collateral circulation defined as minimal or no pial collaterals in >50% of the ischemic territory 4. Expected time between activation of Sonolysis Headframe and initiation of EVT < 90 minutes 5. Pregnant or breast feeding women, clinical signs of pericarditis, sepsis or any other serious medical illness likely to interact with treatment, confounding preexistent neurological or psychiatric disease or test values that, in the opinion of the investigator, pose significant risk to the subject and warrant from the study 6. Impaired renal function defined as eGFR < 60 mL/min/1.73 m2 7. No permanent address or phone number 8. Any investigational drug <14 days prior to study participation 9. Subjects with known allergy to x-ray contrast material 10. Subjects with any standard contraindication for intravenous tPA therapy as per local or national guidelines