Automated Detection and Triage of Large Vessel Occlusions Using Artificial Intelligence for Early and Rapid Treatment (ALERT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2021-12-31

Brief Summary

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Post Market, Prospective, Randomized, Controlled, multi center data collection study to evaluate the use of Viz versus the standard of care in stroke workflow and clinical outcome parameters.

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Detailed Description

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This study will be a multicenter, multi arm, prospective randomized study to evaluate the use of Viz. The study will enroll all subjects that present at all participating centers that meet the study inclusion/exclusion during the period of study evaluation. All subject imaging (CT) data will be pushed to Viz and evaluated by Viz. Randomization will occur at the time of image processing by Viz that indicates the subject is positive for LVO per the software criteria (anterior location). Subjects randomized to the standard of care arm of the study will not receive any information via an automated notification from Viz. Subjects that are randomized to the Viz arm of the study will have an automated message sent to the enrolling center contacts. Subjects will be followed for 90 days post treatment. Data evaluation may occur at regular intervals throughout the study and at the completion of the study period.

Conditions

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Stroke Workflow and Clinical Outcome Parameters

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-Interventional Centers

Cohort A: Viz Subjects Initially Presenting to a Non-Interventional Center The group will be comprised of subjects randomized to Viz and who initially present to a non- interventional center.

Cohort B: Subjects Initially Presenting to a Non-Interventional Center The standard of care group will be comprised of subjects randomized to not have Viz notification and who initially present to a non-interventional center.

Viz Device Software

Intervention Type DEVICE

Viz uses artificial intelligence to automatically detect, triage and notify stroke specialists of suspected large vessel occlusion (LVOs) and computed tomography angiogram (CTA) imaging. Viz includes functionality to automatically process computed tomography perfusion (CTP) images. Additionally, Viz includes a mobile non-diagnostic image viewer and HIPAA-compliant secure messaging.

Interventional Centers

Cohort C: Viz Subjects Initially Presenting to an Interventional Center The group will be comprised of subjects randomized to Viz and who initially present to a interventional center.

Cohort D: Subjects Initially Presenting to a Interventional Center The standard of group will be comprised of subjects randomized to not have Viz notification and who initially present to an interventional center.

Viz Device Software

Intervention Type DEVICE

Viz uses artificial intelligence to automatically detect, triage and notify stroke specialists of suspected large vessel occlusion (LVOs) and computed tomography angiogram (CTA) imaging. Viz includes functionality to automatically process computed tomography perfusion (CTP) images. Additionally, Viz includes a mobile non-diagnostic image viewer and HIPAA-compliant secure messaging.

Interventions

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Viz Device Software

Viz uses artificial intelligence to automatically detect, triage and notify stroke specialists of suspected large vessel occlusion (LVOs) and computed tomography angiogram (CTA) imaging. Viz includes functionality to automatically process computed tomography perfusion (CTP) images. Additionally, Viz includes a mobile non-diagnostic image viewer and HIPAA-compliant secure messaging.

Intervention Type DEVICE

Other Intervention Names

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Viz

Eligibility Criteria

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Inclusion Criteria

1. Age of 18 years or greater.
2. Signs and symptoms consistent with the diagnosis of a stroke.
3. Stroke protocol imaging (CTA) with a confirmed presence of anterior LVO via Viz.

Exclusion Criteria

1. Poor or incomplete CTA imaging data.
2. Disagreement between neuroradiologist and stroke specialist or neurointerventionalist relative to presence of a stroke.
3. Other serious, advanced, or terminal illness (investigator judgment) requiring treatment that significantly delays initiating transfer and/or treatment for stroke.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No