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.
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.
Study Type
OBSERVATIONAL
Enrollment
500
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.
Providence Little Company of Mary Medical Center-Torrance
Torrance, California, United States
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 frame: 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 frame: Time of subject presentation through up to 90 days post treatment.
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 frame: Time of subject presentation through up to 90 days post treatment.
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