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

Study Overview
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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.

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.

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

Conditions
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Stroke Workflow and Clinical Outcome Parameters

Intervention / Treatment
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* Device: Viz Device Software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A subject must meet all of the following inclusion criteria to be included in the study: Age of 18 years or greater. Signs and symptoms consistent with the diagnosis of a stroke. Stroke protocol imaging (CTA) with a confirmed presence of anterior LVO via Viz. Exclusion Criteria: A subject may not be included in the study if any of the following exclusion criteria are met: Poor or incomplete CTA imaging data. Disagreement between neuroradiologist and stroke specialist or neurointerventionalist relative to presence of a stroke. Other serious, advanced, or terminal illness (investigator judgment) requiring treatment that significantly delays initiating transfer and/or treatment for stroke.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-Interventional Centers<br>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. | Device: Viz Device Software<br>* 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.<br>* Other names: Viz;|
| Interventional Centers<br>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. | Device: Viz Device Software<br>* 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.<br>* Other names: Viz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-Interventional Centers | Non-Interventional Centers: Evaluate the Door-In to Door-Out (DIDO) time for subjects in which Viz was utilized versus standard of care. | Time of subject presentation through up to 90 days post treatment. | 
| Interventional Centers | Interventional Centers: Evaluate the Door-In to Groin Puncture time for subjects in which Viz was utilized versus standard of care. | Time of subject presentation through up to 90 days post treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Workflow Endpoints | All endpoints will be evaluated for the rate of differences per arm and cohort assignment. Data related to the overall volume and rates of LVOs evaluated by Viz will be summarized. Data related to the overall volume and rates of treatments (TPA, endovascular intervention) will be summarized. | Time of subject presentation through up to 90 days post treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Large Vessel Occlusion