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

Providence Little Company of Mary-Torrance

Status: Unknown

Conditions: Stroke Workflow and Clinical Outcome Parameters

Treatments: Device: Viz Device Software

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04142879

ALERT-VIZ-LVO-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

A subject must meet all of the following inclusion criteria to be included in the study:

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

A subject may not be included in the study if any of the following exclusion criteria are met:

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.

Trial design

500 participants in 2 patient groups

Non-Interventional Centers

Description:

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.

Treatment:

Device: Viz Device Software

Interventional Centers

Description:

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.

Treatment:

Device: Viz Device Software