Background: The incidence of Large Vessel Acute Ischemic Stroke (AIS) has been estimated to beapproximately 250,000 patients per year in the United States and is the leading cause of disability and fifthleading cause of death. Although interventional (stentriever) and pharmaceutical (tPA) treatments exist forlarge vessel occlusion (LVO), their use is limited due to the short time window from symptom onset that thesetreatments are indicated to be administered in. Moreover, recent estimates suggest only approximately 10% ofeligible patients receive interventional treatment which has shown to lead to better outcomes in severalworldwide RCTs. In order for intervention to be successful, a standardized, quantitative, field based (pre-hospital) diagnostic tool is needed to improve LVO identification and ensure rapid transfer to a capable medicalfacility. Currently, the gold standard for stroke diagnosis is CT angiogram (CTA) which is limited to in-hospitaluse or a low number of mobile stroke ambulances, all costing multi-millions of dollars, requiring expertoperators and IV injection of iodine-rich contrast material. Additionally, the clinical stroke assessment scales(RACE, LAMS, CPSS) used in the field although low cost and non-invasive have proven unreliable due totraining requirements and low inherent accuracies, with SEN and SPE ranging in a recent study from 0.50-0.64and 0.83-0.92, respectively. Goals and Broad Specific Aims: Validate a biomarker for LVO assessment which can be measuredand displayed with a fully automated, non-invasive, transcranial Doppler (TCD) robotic system withperformance at or exceeding 90% ROC-AUC (targeting SEN & SPE greater than 90%) to standard of careimaging. Complete a clinical study where Arm 1 demonstrates technical feasibility of the system in acute strokesettings and Arm 2 demonstrates safety, no detrimental change to standard of care, and collect robust data tosubmit to the FDA an IFU expansion to drive clinical care using our robotic system and the biomarker. Theultimate and future goal of this work is to use the automated device and validated VCI biomarker in aprehospital setting to show improved clinical outcomes after stroke onset due to improved prehospital triage.This work is critical to first validate the biomarker against gold standard CTA, which must be completed in ahospital, to ultimately be used in the pre-hospital setting.Longterm Objective: CTA will not be replaced in comprehensive stroke centers and we do not aim to use ourtechnology to do this in comprehensive centers with CTA. Instead, our technology will be available in centerswithout CTA or MRA and ultimately in the prehospital environment. The goal of our company is to show thatour lower cost, portable, non invasive technology can be used to measure a valid biomarker of large vesselocclusion that can be performed outside of a comprehensive stroke center. The first step is to validate thebiomarker, in a center with CTA as a gold standard, which is the ultimate goal of this work.
Public Health Relevance Statement: The incidence of Large Vessel Acute Ischemic Stroke (AIS) has been estimated to be approximately 250,000
patients per year in the United States and is the leading cause of disability and fifth leading cause of death.
This work will validate a biomarker for large vessel occlusion (LVO) assessment which can be measured and
displayed with a fully automated, non-invasive, transcranial Doppler (TCD) robotic system with performance at
or exceeding 90% ROC-AUC (targeting SEN & SPE greater than 90%) to standard of care imaging. The
ultimate goal of this work is to use the automated device and validated LVO biomarker in a prehospital setting
to show improved clinical outcomes after stroke onset due to improved prehospital triage.
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