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

A Single-center, Clinical Trial to Evaluate the Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic Stroke

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.

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