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

NovaSignal

Status: Terminated

Conditions: Stroke; Acute Ischemic Stroke

Treatments: Device: NovaGuide 2 Intelligent Ultrasound System

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT05547412

NA-01STR-03

U44NS109952 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

The purpose of this study is to collect robust data from NovaGuide 2 Intelligent Ultrasound System to validate the Velocity Curvature Index (VCI) as a diagnostic biomarker tool to drive clinical decision making for assessing cerebral vascular occlusions confirmed by standard of care Computed Tomography Angiography (CTA) imaging.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

27 participants in 6 patient groups

Cohort X

Description:

Phase 0 will include up to 20 subjects in Cohort X (TCD). This phase is for training and feasibility purposes only and data collected will not be used in the final analysis.

Treatment:

Device: NovaGuide 2 Intelligent Ultrasound System

Cohort Y

Description:

Phase 0 will include up to 20 subjects in Cohort Y (No TCD). This phase is for training and feasibility purposes only and data collected will not be used in the final analysis.

Cohort A

Description:

Both Phase 1 and Phase 2 of the study will enroll Cohort A (LVO TCD). Cohort A will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2

Treatment:

Device: NovaGuide 2 Intelligent Ultrasound System

Cohort B

Description:

Both Phase 1 and Phase 2 of the study will enroll Cohort B (Non-LVO TCD). Cohort B will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2

Treatment:

Device: NovaGuide 2 Intelligent Ultrasound System

Cohort C

Description:

Both Phase 1 and Phase 2 of the study will enroll Cohort C (LVO No-TCD). Cohort C will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2

Cohort D

Description:

Both Phase 1 and Phase 2 of the study will enroll Cohort D (Non-LVO No-TCD). Cohort D will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2