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

NCT03519737 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 596

Last updated 2018-11-30

No results posted yet for this study

Summary

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.

Conditions

  • Acute Ischemic Stroke

Interventions

DEVICE

tPA in combination with the Sonolysis Headframe (TUS)

tPA: 60 minutes per approved labeling TUS insonation via the Sonolysis Headframe: minimum 90 minutes - maximum 120 minutes

DEVICE

tPA in combination with the Sonolysis Headframe (Sham TUS)

tPA per approved labeling Sham (inactive) TUS insonation via the Sonolysis Headframe: minimum 90 minutes - maximum 120 minutes

Sponsors & Collaborators

  • Cerevast Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrei V Alexandrov, MD · University of Tennessee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-17
Primary Completion
2021-11-30
Completion
2021-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03519737 on ClinicalTrials.gov