Stroke Workflow and Clinical Outcome Parameters
Conditions
Keywords
Large Vessel Occlusion
Brief summary
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
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.
Interventions
DEVICEViz 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.
Sponsors
Viz.ai, Inc.
Providence Little Company of Mary-Torrance
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-Interventional Centers | Time of subject presentation through up to 90 days post treatment. | Non-Interventional Centers: Evaluate the Door-In to Door-Out (DIDO) time for subjects in which Viz was utilized versus standard of care. |
| Interventional Centers | Time of subject presentation through up to 90 days post treatment. | Interventional Centers: Evaluate the Door-In to Groin Puncture time for subjects in which Viz was utilized versus standard of care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Workflow Endpoints | Time of subject presentation through up to 90 days post treatment. | 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. |
Countries
United States
Contacts
Primary ContactDiana Gallegos, LVN
Backup ContactTreasure Joyce, LVN
Outcome results
None listed