The Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic Stroke

Cvaid Medical

Status: Enrolling

Conditions: Stroke, Cardiovascular; Stroke; Stroke Hemorrhagic; Stroke, Acute; Stroke, Ischemic

Treatments: Diagnostic Test: CVAid Flow

Study type: Interventional

Funder types: Industry

Identifiers

NCT05745051

0091-22-SZMC

Details and patient eligibility

About

The purpose of this study is to demonstrate the effectiveness and safety of CVA-FLOW, a digital health AI based Telestroke system developed by CVAID Ltd. Company aims to assist certified medical staff to triage acute ischemic stroke patients using dedicated algorithms in order to support application for market approval for CVA-FLOW device.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Suspected hyper-acute stroke patient at the ED, prior to treatment (tPA or EVT)
• Age≥18

Exclusion criteria

• Intubated patients upon arrival
• Time from stroke symptoms onset > 24h
• Patients post treatment (tPA of EVT)
• Patient in acute psychosis state
• Patients who do not speak Hebrew as their mother tongue

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Evaluate the safety and effectiveness of CVA-FLOW Software Device for acute ischemic stroke

Experimental group

Description:

The purpose of this study is to demonstrate the effectiveness and safety of CVA-FLOW, a digital health AI based Telestroke system developed by CVAID Ltd. Company aims to assist certified medical staff to triage acute ischemic stroke patients using dedicated algorithms in order to support application for market approval for CVA-FLOW device.

Treatment:

Diagnostic Test: CVAid Flow