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Thrombolytic Agent

Treatment group (tPA + TUS) for Stroke (TRUST Trial)

N/A
Waitlist Available
Led By Andrei V Alexandrov, MD
Research Sponsored by Cerevast Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90-120 minutes post tus treatment before evt
Awards & highlights

TRUST Trial Summary

This trial will test whether transcranial ultrasound, used with IV tissue plasminogen activator, is more effective than using tPA alone to treat acute ischemic stroke.

Eligible Conditions
  • Stroke

TRUST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90-120 minutes post tus treatment before evt
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90-120 minutes post tus treatment before evt for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete recanalization measured by modified Arterial Occlusive Lesion (mAOL)
Secondary outcome measures
Neurologic Status at 24 hours post treatment measured by National Institute of Health's Stroke Scale (NIHSS).
Cerebral Infarction
Partial or complete recanalization as measured by mAOL score of 2-3.
+1 more

TRUST Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Treatment group (tPA + TUS)Active Control1 Intervention
Treatment group (tPA + TUS): Lead-in phase and Primary phase
Group II: Control group (tPA + sham TUS)Placebo Group1 Intervention
Control group (tPA + sham TUS) During the primary phase of the study, subjects will be randomized 1:1

Find a Location

Who is running the clinical trial?

Cerevast Medical, Inc.Lead Sponsor
Andrei V Alexandrov, MDPrincipal InvestigatorUniversity of Tennessee
1 Previous Clinical Trials
316 Total Patients Enrolled
1 Trials studying Stroke
316 Patients Enrolled for Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
CirculationJournal
Heart Disease and Stroke Statistics—2016 Update
Mozaffarian, Dariush, Emelia J. Benjamin, Alan S. Go, Donna K. Arnett, Michael J. Blaha, Mary Cushman, Sandeep R. Das, et al.. 2016. “Heart Disease and Stroke Statistics—2016 Update”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/cir.0000000000000350.
New England Journal of MedicineJournal
Randomized Assessment of Rapid Endovascular Treatment of Ischemic Stroke
Goyal, Mayank, Andrew M. Demchuk, Bijoy K. Menon, Muneer Eesa, Jeremy L. Rempel, John Thornton, Daniel Roy, et al.. 2015. “Randomized Assessment of Rapid Endovascular Treatment of Ischemic Stroke”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1414905.
clinicaltrials.govStudy
Aureva Transcranial Ultrasound Device With tPA in Patients With Acute Ischemic Stroke
2018. "Aureva Transcranial Ultrasound Device With tPA in Patients With Acute Ischemic Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03519737.
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