Aureva Transcranial Ultrasound Device With tPA in Patients With Acute Ischemic Stroke

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Acute Ischemic Stroke

In brief

This is a randomized, placebo controlled, double-blind phase 3 clinical study to evaluate the efficacy and safety of transcranial ultrasound (TUS) using the Sonolysis Headframe as an adjunctive therapy to intravenous (IV) tissue plasminogen activator (tPA) therapy in subjects with acute ischemic stroke that initially present at non-endovascular (EVT) treating hospitals that have established transport services in place to transfer subjects to hospitals capable of performing EVT.

Key facts

Study ID

NCT03519737

Run by

Cerevast Medical, Inc.

People needed

596

Starts

2018-08-17

Expected to finish

2021-12-31

Last updated by the study team

2018-11-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with acute ischemic stroke
• 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
• Males or females 18 - 80 years of age
• 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
• No signs of intracranial bleeding on assessment by non-contrast CT
• 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
• SBP ≤ 185 mmHg and DBP ≤ 105 mmHg at baseline or after treatment of hypertension with medications prior to tPA bolus
• Pre-morbid mRS of 0-1
• 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)
• 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

You may not qualify if…

• Tandem lesions where one lesion is extracranial (carotid or vertebral artery)
• ASPECTS score < 6 on non contrast CT or ischemic changes that in the opinion of the investigator would be medically inappropriate for reperfusion therapy
• Poor collateral circulation defined as minimal or no pial collaterals in >50% of the ischemic territory
• Expected time between activation of Sonolysis Headframe and initiation of EVT < 90 minutes
• 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 exclusion from the study
• Impaired renal function defined as eGFR < 60 mL/min/1.73 m2
• No permanent address or phone number
• Any investigational drug <14 days prior to study participation
• Subjects with known allergy to x-ray contrast material
• Subjects with any standard contraindication for intravenous tPA therapy as per local or national guidelines

Where it is running

• The University of Tennessee Health Science Center — Memphis, Tennessee, United States
• Memorial Hermann Hospital - Texas Medical Center (TMC) — Houston, Texas, United States

Full record on ClinicalTrials.gov

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