The Innovation Impulse study is an ongoing prospective sequential cohort trial that started on January 1st 2018 and is established across Dutch stroke centers, where the stroke care Pre-StrokeViewer is already of a very good standard. The clinical trials includes patients aged 18 years or older with a clinical diagnosis of stroke due to a Large Vessel Occlusion (LVO) in the Internal Carotid Artery (ICA) and/or in the first and second segments of the middle cerebral artery (MCA M1, M2) detected on CT angiography scans.
The aim of the study is to optimize the stroke clinical workflow between primary and comprehensive stroke centers in The Netherlands through the use of AI aimed at identifying large vessel occlusions. The primary outcome measure of this study is to evaluate the impact of StrokeViewer implementation on treatment times (door primary stroke center to groin puncture time). Additionally, the trial further examines the clinical and economic impact of StrokeViewer on parameters including futile transfers, patients’ access to care, patients’ short- and long-term functional outcomes, and hospital revenue.
Preliminary results available December 2020 showed the following from 41 patients that were referred to the intervention center and treated with Endovascular Treatment (EVT) < 6 hours.
Data collection is currently ongoing and completion time is estimated to be December 31st 2021.
StrokeViewer decreases delays and reduces the time to intervention.
|Door-to-groin puncture time in minutes – median (IQR)||135 (111.5 – 158.5)||112 (93 – 114.5)|
StrokeViewer helps to improve the rate of reperfusion.
Physicians can use the treatment planning tool in StrokeViewer to be better prepared for EVT. StokeViewer has also proven to decrease the median door-to-groin-puncture time which are both factors that contribute to increased reperfusion rates, and therefore improved patient outcome.
|Reperfusion (EVT success) – (%)||82.4%||91.7%|
StrokeViewer improves patient outcome.
NIHSS 24-48 hours after stroke is the most important predictor of 90-day functional outcome on modified Rankin Scale.
|NIHSS after 24-48 hours – median (IQR)||11 (4-19)||8 (4 -17)|
|Good functional outcome (mRS 0-2 at 90 days) – (%)||36.8%||63.6%|
StrokeViewer Reduces undetected LVOs.
A recent study by Fasen et al. found that 20% of LVOs are initially undetected by stroke experts. Our LVO Detection algorithm has a high sensitivity that means fewer than 20% of LVOs would go undetected.
ICA and M1
Data from our FDA Submission.