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

Last updated: August 29, 2023
Sponsor: Cvaid Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Stroke

Myocardial Ischemia

Treatment

CVAid Flow

Clinical Study ID

NCT05745051
0091-22-SZMC
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: CVAid Flow
Phase:
Study Start date:
November 08, 2022
Estimated Completion Date:
November 30, 2023

Connect with a study center

  • Shaare Zedek Medical Center

    Jerusalem,
    Israel

    Active - Recruiting

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