SOFIA Aspiration System as first-line Technique (SOFAST): a prospective, multicenter study to assess the efficacy and safety of the 6 French SOFIA Flow Plus aspiration catheter for endovascular stroke thrombectomy.

Background: Mechanical thrombectomy (MT) is the standard of care for acute ischemic stroke (AIS) patients with large vessel occlusion (LVO). The SOFAST study collected clinical evidence on the safety and efficacy of the 6 French SOFIA Flow Plus aspiration catheter (SOFIA 6F) when used as first-line treatment.
Methods: This was a prospective, multicenter investigation to assess the safety and efficacy of SOFIA 6F used for first-line aspiration. Anterior circulation LVO stroke patients were enrolled. The primary endpoint was the final modified Thrombolysis in Cerebral Infarction (mTICI)≥2b rate. Secondary endpoints included first-pass and first-line mTICI≥2b rates, times from arteriotomy to clot contact and mTICI≥2b, and 90-day modified Rankin Scale (mRS)≤2. First-line and final mTICI scores were adjudicated by an independent imaging core lab. Safety events were assessed by an independent clinical events adjudicator.
Results: A total of 108 patients were enrolled across 12 centers from July 2020 to June 2022. Median age was 67 years, median National Institutes of Health Stroke Scale (NIHSS) was 15.5, and 56.5% of patients received intravenous thrombolytics. At the end of the procedure, 97.2%, 85.2%, and 55.6% of patients achieved mTICI≥2b, ≥2c, and 3, respectively. With SOFIA 6F first-line aspiration, 87.0%, 79.6%, and 52.8% achieved mTICI≥2b, ≥2c, and 3, respectively. After the first pass, 75.0%, 70.4%, and 50.9% achieved mTICI≥2b, ≥2c, and 3, respectively. Median times from arteriotomy to clot contact and successful revascularization were 12 and 17 min, respectively. At 90 days, 66.7% of patients achieved mRS≤2.
Conclusions: First-line aspiration with SOFIA 6F is safe and effective with high revascularization rates and short procedure times.
Competing Interests: Competing interests: DG: research funding from the National Institutes of Health, Focused Ultrasound Foundation, MicroVention, University of Calgary, and University of Maryland Medical Center; consultant for Navigantis. CS: research support from MicroVention, National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS), Balt, Penumbra, Medtronic, Cerenovus, Route 92, MIVI, Stryker; consultant for Medtronic, Stryker, Balt, Werfen, Viz.ai, MicroVention; shareholder for Neurotechnology Investors, REIST. DHS: consultant for Medtronic, Stryker, and Kaneka; speaker for Medtronic; proctor for Medtronic; grant support from MicroVention; advisory board for Scientia and Vasorum; stockholder of Scientia and Vasorum. GT: consultant for Dynamed, Medtronic, and Penumbra. DF: consultant for Medtronic, Cerenovus, MicroVention, Penumbra, Stryker, Balt USA, MENTICE, Neurogami, RAPID. AI, RAPID Medical, Phenox Medical, Scientia Medical, Perfuze, Vesalio; proctor for Medtronic, MicroVention; research support from MicroVention, Penumbra, Stryker, Balt USA, Siemens; advisory board on Arsenal Medical, NVMed, Perfuze; stock holder in Neurogami, Arsenal Medical, Scientia Medical, NVMed, and Perfuze.
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