Acute Ischemic Stroke Clinical Trial
Official title:
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of the Aureva Transcranial Ultrasound Device With Tissue Plasminogen Activator in Patients With Acute Ischemic Stroke (TRUST)
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.
The primary objective of this study is to assess the safety and efficacy of TUS using the
Sonolysis Headframe in combination with systemic tPA (Treatment group) compared to systemic
tPA alone (Control group) in subjects with acute ischemic stroke.
Number of Subjects Required:
Lead-in Phase: 40 subjects in the U.S.; Primary Phase: 556 total enrolled subjects (278 per
arm)
Number of Study Centers:
Lead-in Phase: Up to 20 Institutions in U.S.; Primary Phase: Up to 70 Institutions worldwide
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