Multicenter clinical trial evaluating the safety and efficacy of mechanical thrombectomy using the Versi Retriever.

Abstract

This study aimed to elucidate the safety and efficacy of mechanical thrombectomy using the Versi Retriever in patients with acute ischemic stroke (AIS). This was a prospective, multicenter, single-arm study conducted at 10 institutes in Japan from December 2018 to March 2021 on mechanical thrombectomy using the Versi Retriever in patients with AIS. The primary efficacy outcome was the modified Rankin scale (mRS) 0-2 at 90 days after the procedure. The primary safety outcome was mortality within 90 days after the procedure. Fifty-eight patients with a mean age of 72.7 years were enrolled in the study. The primary efficacy outcome of mRS 0-2 at 90 days was 62.0% (95% CI 47.2-75.3%) in patients within 8 hours of stroke onset. The rate of immediate reperfusion of Thrombolysis in Cerebral Infarction (TICI) grade 2b-3 using the Versi Retriever in three passes was 78.0% (64.0-88.5%). The rate of final reperfusion of TICI 2b-3 was 100% (92.9-100%). The primary safety outcome of mortality within 90 days was 8.0% (2.2-19.2%) in patients within 8 hours of AIS onset. The incidence of intracranial hemorrhage within 24 hours was 12.0% (4.5-24.3%) for symptomatic cases and 32.0% (19.5-46.7%) for asymptomatic cases. The Versi Retriever proved to be a safe and effective option for mechanical thrombectomy in patients with AIS.