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InspireMD Announces Late-Breaking Presentation of Early SIBERIA Clinical Trial Results to be Featured in an e-Course at EuroPCR
In a head-to-head evaluation, significantly fewer silent brain infarcts were associated with CGuard™ EPS versus Acculink™ at 30 days post-procedure TEL AVIV,
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[{"type":"text","content":"In a head-to-head evaluation, significantly fewer silent brain infarcts were associated with CGuard™ EPS versus Acculink™ at 30 days post-procedure\nTEL AVIV, Israel, June 25, 2020 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease treatment, announced today that early results from the investigator-initiated SIBERIA randomized clinical trial of CGuard™ EPS are being featured as a late-breaking presentation in an EuroPCR e-Course, which is being held June 25-27, 2020. The study evaluated 30-day silent brain infarcts associated with the use of the Acculink™ conventional open-cell nitinol stent vs the CGuard™ Micronet™-covered stent.\n Title: The SIBERIA trial for carotid artery stenosis: A randomized controlled trial of conventional versus Micronet™-covered stent use in percutaneous neuroprotected carotid artery revascularization: Peri-procedural and 30-day diffusion-weighted magnetic resonance imaging and clinical outcomes Presenter: Pavel Ignatenko, MD, E.N. Meshalkin Siberian Federal Biomedical Research Center, Ministry for Public Health of the Russian Federation, Novosibirsk, Russia Date: June 25, 2020 Time: 4:00pm CEST (10:00am EDT) The SIBERIA trial evaluated one hundred patients who qualified for carotid revascularization with high risk for surgery and were randomized 1:1 to either CGuard or Acculink™. Primary endpoints were incidence and volume of new cerebral embolic post-procedural lesions (24-48 hours) as determined by diffusion weighted magnetic resonance imaging (DW-MRI). Principal secondary endpoints included incidence of periprocedural or postprocedural stroke, myocardial infarction and death at 30 days. Post Procedure (24-48 hours), the CGuard™ arm was observed to have a 78% reduction in the average volume of new cerebral lesions (157 mm3 vs. 700 mm3), a statistically significant improvement (p=0.007)At 30 days, DW-MRI showed zero new cerebral lessons in the CGuard™ arm versus six in the Acculink™ arm (p=0.03)At 30 days, there were zero strokes, myocardia infarctions or deaths in the CGuard arm and three events the Acculink™ arm (two strokes and one myocardial infarction) Dr. Ignatenko stated, “CGuard™ Micronet™-covered stent use in consecutive unselected patients subjected to neuroprotecte...