VOICE: Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort X 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
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.
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| Cohort Y 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. |
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| Cohort A 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
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.
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| Cohort B 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
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.
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| Cohort C 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 |
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| Cohort D 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 |
Outcome Measures
Primary Outcome Measures
- Primary Endpoint: Area Under the Curve (AUC), Sensitivity, and Specificity of VCI when compared against standard of care imaging. [42 months]
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.
Secondary Outcome Measures
- Safety Endpoint: Incidence of device-related serious adverse events [42 months]
Measuring incidence of device-related serious adverse events as defined by the study protocol.
- Safety Endpoint: Last Known Normal (LKN) to first hospital arrival (initial door-in) time [42 months]
Measuring the time from the subject's last known normal health to the time the subject first arrive in the hospital.
- Safety Endpoint: Door to initial CT imaging (non-contrast) time [42 months]
Measuring the time from when the subject first arrive at the hospital to the time the subject receives the initial CT imaging.
- Safety Endpoint: Door to IV-tPA time [42 months]
Measuring the time from when the subject first arrive at the hospital to the time the subject receives IV-tPA
- Safety Endpoint: Door to initial CTA acquisition time [42 months]
Measuring the time from when the subject first arrive at the hospital to the time the initial CTA was acquired.
- Safety Endpoint: Door to Groin Puncture time [42 months]
Measuring the time from when the subject first arrive at the hospital to the time the groin was punctured.
- Safety Endpoint: CTA Acquisition to Groin Puncture time [42 months]
Measuring the time from the CTA acquisition to the time the groin was punctured
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject aged 18 years and older referred for evaluation of possible stroke.
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Subject receives Computed Tomography Angiography (CTA) imaging for the assessment of stroke.
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Subject or Legally Authorized Representative has the ability to provide informed consent and comply with the protocol.
Exclusion Criteria:
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Head CT findings consistent with acute primary intracranial hemorrhage (SAH, ICH, etc.)
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Subjects with occlusions in the distal or posterior circulation arteries.
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Subjects who underwent partial or full craniotomy
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Additional intracranial pathologies present (tumor, hydrocephalus, etc.)
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Anticipated insufficient time to acquire a complete TCD scan as described by the protocol
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Subjects who have a physical limitation preventing placement of the system.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHI Memorial Hospital | Chattanooga | Tennessee | United States | 37404 |
Sponsors and Collaborators
- NovaSignal Corp.
- National Institutes of Health (NIH)
- National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
- Principal Investigator: Robert Hamilton, Ph.D., NovaSignal Corp.
Study Documents (Full-Text)
None provided.More Information
Publications
- Hastrup S, Damgaard D, Johnsen SP, Andersen G. Prehospital Acute Stroke Severity Scale to Predict Large Artery Occlusion: Design and Comparison With Other Scales. Stroke. 2016 Jul;47(7):1772-6. doi: 10.1161/STROKEAHA.115.012482. Epub 2016 Jun 7.
- Jalaleddini K, Canac N, Thorpe SG, O'Brien MJ, Ranjbaran M, Delay B, Dorn AY, Scalzo F, Thibeault CM, Wilk SJ, Hamilton RB. Objective Assessment of Beat Quality in Transcranial Doppler Measurement of Blood Flow Velocity in Cerebral Arteries. IEEE Trans Biomed Eng. 2020 Mar;67(3):883-892. doi: 10.1109/TBME.2019.2923146. Epub 2019 Jun 17.
- Smith EE, Kent DM, Bulsara KR, Leung LY, Lichtman JH, Reeves MJ, Towfighi A, Whiteley WN, Zahuranec DB; American Heart Association Stroke Council. Accuracy of Prediction Instruments for Diagnosing Large Vessel Occlusion in Individuals With Suspected Stroke: A Systematic Review for the 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke. Stroke. 2018 Mar;49(3):e111-e122. doi: 10.1161/STR.0000000000000160. Epub 2018 Jan 24. Review. Erratum in: Stroke. 2018 Mar;49(3):e139.
- Thorpe SG, Thibeault CM, Canac N, Wilk SJ, Devlin T, Hamilton RB. Decision Criteria for Large Vessel Occlusion Using Transcranial Doppler Waveform Morphology. Front Neurol. 2018 Oct 17;9:847. doi: 10.3389/fneur.2018.00847. eCollection 2018.
- Thorpe SG, Thibeault CM, Wilk SJ, O'Brien M, Canac N, Ranjbaran M, Devlin C, Devlin T, Hamilton RB. Velocity Curvature Index: a Novel Diagnostic Biomarker for Large Vessel Occlusion. Transl Stroke Res. 2019 Oct;10(5):475-484. doi: 10.1007/s12975-018-0667-2. Epub 2018 Oct 6.
- NA-01STR-03
- U44NS109952