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TriGUARD 3™ Treatment Effect Across Populations
Low In-Hospital Disabling
Stroke Rates
Despite treating significantly more patients with prior stroke/TIA (versus the control arm), the TriGUARD 3™ CEP device showed a lower numerical in-hospital disabling stroke rate.
Stroke Timing:
VARC2 Defined
No strokes were adjudicated as related or probably related to the TriGUARD 3 Device
In-Hospital Disabling Stroke
Clinically Meaningful Lesion Reduction
Patient with 3 vessel coverage per the TriGUARD 3™ CEP device experienced a numerical 26% relative reduction in mean total lesion volume. Post-hoc MRI analyses also suggests a benefit in reducing clinically significant large lesions with the TriGUARD 3™ CEP Device
Lesion Size Threshold Analysis
Suprathreshold Lesion Volume Analysis in eITT and PT
P=NS for all comparisons
Suprathreshold Lesion Volume Analysis in eITT and PT
TriGUARD 3™ Treatment Effect Across Populations
Average total new supra-threshold cerebral ischemic lesion (SCIL) volume analysis across subjects by randomization Group in the efficacy Intention-To-Treat study population (eITT) and Per Treatment (PT). P-values are differences in Slopes for treatment by threshold.
Average total new supra-threshold cerebral ischemic lesion (SCIL) volume analysis across subjects by randomization Group in the efficacy Intention-To-Treat study population (eITT) and Per Treatment (PT). P-values are differences in Slopes for treatment by threshold.
The study shows correlation between subjects’ total lesion volume (SCIL) and NIHSS changes was higher when eliminating very small lesions <500mm³.
Even with the intervention effect, correlation was still maximized when very
small lesions <200mm³ were eliminated.
Safety Delivered
The TriGUARD 3™ Cerebral Embolic Protection Device (CEP) achieved the primary non-inferiority safety endpoint with statistical significance, Demonstrating the device is safe compared to historical Transcatheter Aortic Valve Replacement (TAVR) data
