Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke

Stopped early

Conditions studied: Stroke, Acute Ischemic Stroke

In brief

This study is a multi-center, multi-phase, multi-cohort, prospective, randomized, open, blinded endpoint (PROBE), non-significant risk (NSR) device study including up to 420 evaluable subjects measured with the study device(s) and up to 40 non-evaluable subjects for the training phase.

Key facts

Study ID

NCT05547412

Run by

NeuraSignal Inc dba NovaSignal

People needed

27

Starts

2022-09-21

Expected to finish

2023-01-31

Last updated by the study team

2024-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject aged 18 years and older referred for evaluation of possible stroke.
• Subject receives Computed Tomography Angiography (CTA) imaging for the assessment of stroke.
• Subject or Legally Authorized Representative has the ability to provide informed consent and comply with the protocol.

You may not qualify if…

• Head CT findings consistent with acute primary intracranial hemorrhage (ICH), etc.
• Subjects with occlusions in the distal or posterior circulation arteries.
• Subjects who underwent partial or full craniotomy
• Additional intracranial pathologies present (tumor, hydrocephalus, etc.)
• Anticipated insufficient time to acquire a complete TCD scan as described by the protocol
• Subjects who have a physical limitation preventing placement of the system.

Where it is running

• CHI Memorial Hospital — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

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