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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stroke, Acute Ischemic Stroke

Intervention / Treatment
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* Device: NovaGuide 2 Intelligent Ultrasound System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Head CT findings consistent with acute primary intracranial hemorrhage (SAH, 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort X<br>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. | Device: NovaGuide 2 Intelligent Ultrasound System<br>* The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows.<br>|
| Cohort Y<br>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<br>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 | Device: NovaGuide 2 Intelligent Ultrasound System<br>* The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows.<br>|
| Cohort B<br>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 | Device: NovaGuide 2 Intelligent Ultrasound System<br>* The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows.<br>|
| Cohort C<br>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<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint: Area Under the Curve (AUC), Sensitivity, and Specificity of VCI when compared against standard of care imaging. | The primary endpoint for both Phase 1 and Phase 2 of the study is to measure the AUC, Sensitivity, and Specificity of Velocity Curvature Index (VCI) when compared against standard of care CTA imaging for large vessel occlusion assessment. Initial assessment of outcome will be done after 18 months of study start and complete assessment will be done at the end of study's Phase 2. | 42 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Endpoint: Incidence of device-related serious adverse events | Measuring incidence of device-related serious adverse events as defined by the study protocol. | 42 months | 
| Safety Endpoint: Last Known Normal (LKN) to first hospital arrival (initial door-in) time | Measuring the time from the subject's last known normal health to the time the subject first arrive in the hospital. | 42 months | 
| Safety Endpoint: Door to initial CT imaging (non-contrast) time | Measuring the time from when the subject first arrive at the hospital to the time the subject receives the initial CT imaging. | 42 months | 
| Safety Endpoint: Door to IV-tPA time | Measuring the time from when the subject first arrive at the hospital to the time the subject receives IV-tPA | 42 months | 
| Safety Endpoint: Door to initial CTA acquisition time | Measuring the time from when the subject first arrive at the hospital to the time the initial CTA was acquired. | 42 months | 
| Safety Endpoint: Door to Groin Puncture time | Measuring the time from when the subject first arrive at the hospital to the time the groin was punctured. | 42 months | 
| Safety Endpoint: CTA Acquisition to Groin Puncture time | Measuring the time from the CTA acquisition to the time the groin was punctured | 42 months |