Automated Detection and Triage of Large Vessel Occlusions Using Artificial Intelligence for Early and Rapid Treatment (ALERT)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Non-Interventional Centers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Non-Interventional Centers
时间窗: 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
时间窗: 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.
次要结局
- Workflow Endpoints(Time of subject presentation through up to 90 days post treatment.)
研究者
Jason Tarpley, M.D.
Neurointerventionist
Providence Little Company of Mary-Torrance