A75 Thunderbolt modulated aspiration system for acute ischemic stroke secondary to large vessel occlusion: novel technology overview and thunder trial design

Introduction Advances in aspiration thrombectomy have traditionally focused on access, catheter designs and delivery technologies. Modulated aspiration has emerged as a method for further improving the efficacy clot removal but has not yet been studied in stroke.Aim of Study THUNDER ( NCT05437055) assesses the safety and efficacy of modulated aspiration thrombectomy (Penumbra Thunderbolt System) in AIS secondary to large vessel occlusion (LVO).Method THUNDER is prospective, single-arm, multicenter premarket study with core lab adjudication and CEC/DSMB oversight. The study included 29 US Institutions and enrolled 216 AIS patients with pre-stroke modified Rankin Scale (mRS) 0–2, Alberta Stroke Program Early CT Score (ASPECTS) greater than 6 (or core infarct volume ≤50 mL on MRI/CT imaging), and frontline treatment with the Penumbra Thunderbolt System within 8h of symptom onset.Results Primary endpoint is angiographic revascularization (mTICI 2b or higher) of occluded target vessel immediate post-procedure. Secondary endpoints include angiographic revascularization of occluded target vessel after first pass (mTICI 2b or higher) and immediate post-procedure (mTICI 2c or higher), time to revascularization, mRS 0–2 at 90-days, symptomatic intracranial hemorrhage (sICH) at 24 hours, all-cause mortality at 90-days, device related and/or procedure related Serious Adverse Events (SAEs) within 24 hours post-procedure. Data analysis is ongoing and unavailable at the time of submission.Abstract A75 Table 1Primary and secondary endpointsConclusion The present study represents the first prospective trial of modulated aspiration for the treatment of emergent LVO and acute ischemic stroke. The complete dataset ( table 1) will be available before the meeting and abstract can be updated in advance.Conflict of Interest Yes Dr. Fiorella, Research Support from Blast USA, Microvention, Penumbra, Stryker, Siemens; Consulting agreement with Cerenovous, Elixer Medical, Medtronic, MENTICE-Vascular Simulations, Microvention, Penumbra, Perfuze, Phenox Medical, Qapel Medical, RAPID.AI, RAPID Medical, Scientia Medical, Stryker, Vesalio; Teaching agreement with Medtronic and Microvention; Member of Advisory Board at Arsenal Medical, NVMed, Scientia Medical; Deputy Editor for JNIS; Equity interest in Arsenal Medical, NVMed, Perfuze, Scientia Medical