Article Text
Abstract
Introduction The NeVa stent retriever has proven it’s safety and performance for treating large vessel occlusion (LVO) in acute ischemic stroke (AIS) across multiple clinical studies including the most recently published CLEAR Trial. This trial was conducted under rigorous scrutiny, with independent boards adjudicating outcomes. Real-world data is helpful in assessing the reproducibility of patient outcomes.
Aim of Study NeVa ONE is a multicenter, international, prospective registry designed to assess outcomes in a real-world cohort of patients.
Methods AIS LVO patients treated with NeVa either as first-line or as a rescue device are included. This interim analysis reports performance results of 175 subjects from 15 centers in 7 countries treated with NeVa used as first-line device. Study endpoints are successful (TICI2b-3) and/or complete (TICI 2c-3) recanalization at first pass (mFPE/FPE), up to three passes, and at procedure end. Secondary endpoints include neurological deterioration at 24 hours and device/procedure-related adverse events.
Results Mean patient age was 71±14 years. Most frequently reported conditions in medical history included: Hypertension (39%); Dyslipidemia (19%); Diabetes (14%) and Atrial Fibrillation (14%). Median admission-NIHSS was 16 (IQR:12–20). IV-tPA was administered in 43,1% of subjects. Occlusion sites were: ICA (23%), MCA (71%), posterior circulation (5%), and ACA (1%). Recanalization rates were: mFPE: 72.6%; FPE: 58.3%; ≤3pass eTICI 2b-3: 90.9%; ≤3pass eTICI 2c-3: 76.0%; Final eTICI 2b-3: 98.9% and final eTICI 2c-3: 83.4%.
Conclusion NeVa ONE Registry represents real-world data obtained from LVO AIS subjects treated with NeVa.
Disclosure of Interest Nothing to disclose