Suspended

TRUSTA 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)

What is being tested

tPA in combination with the Sonolysis Headframe (TUS)

+ tPA in combination with the Sonolysis Headframe (Sham TUS)

Device

Who is being recruted

Ischemic Stroke+5

+ Brain Diseases

+ Cardiovascular Diseases

From 18 to 80 Years

+20 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled

Interventional

Study Start: August 2018

See protocol details

Summary

Principal SponsorCerevast Medical, Inc.

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 17, 2018

Actual date on which the first participant was enrolled.

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

Official TitleA 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)

NCT03519737

Principal SponsorCerevast Medical, Inc.

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

596 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Ischemic StrokeBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesVascular DiseasesStroke

Criteria

10 inclusion criteria required to participate

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

Show More Criteria

10 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Treatment group (tPA + TUS): Lead-in phase and Primary phase

Group II

Sham

Control group (tPA + sham TUS) During the primary phase of the study, subjects will be randomized 1:1

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

The University of Tennessee Health Science Center

Memphis, United StatesOpen The University of Tennessee Health Science Center in Google Maps

Suspended

Memorial Hermann Hospital - Texas Medical Center (TMC)

Houston, United States

Suspended2 Study Centers