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Raul Nogueira, MD; Marc Ribo, MD; Arsida Bajrami, MD; Eren Erdem, MD; Demet Funda Baş, MD; Songul Senadim, MD; Ricardo Mernes, MD; Christian Otto, MD; Fatima Pedrozo, MD; Cesar Caballero, MD; Gonzalo Aranda, MD; Gerardo Muller, MD; Serdar Geyik, MD
A total of 25 patients were screened, and 19 patients were enrolled across two sites in Turkey and Paraguay between 23 March 2024 and 22 October 2024. The mean baseline stroke severity was 17.5 +5.3 as assessed by NIHSS and mean ASPECT score was 7.8 + 1.8. The time from stroke onset to intervention was 6.8 hours. None of the subjects received IV thrombolytic therapy (tPA or TNK). More females (73.7%) were enrolled than males (26.3%), which is attributed to the demographic imbalance caused by chance due to the small sample size. The mean age at enrollment was 74. The medical history was as expected for this population. Most (68.4%) occlusions were in the M1 territory, followed by 26.3% in the ICA territory and 5.3% (one subject) had an M2 occlusion.
Thirteen (13/19, 68.4%) subjects achieved the primary endpoint of First Pass Reperfusion Effect (FPE), defined as mTICI ≥2c after one reperfusion attempt. Following the final device pass, all 19 subjects (100%) achieved mTICI 2b or greater therapy and 89.5% (17/19) achieved mTICI ≥ 2c without rescue treatment.
The RapidPulse® System is not yet cleared for marketing by the US Food & Drug Administration. It is not available for commercial sale.
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