Abstract 004: Early Feasibility Study of RapidPulse® Aspiration System as Frontline Approach for Patients with Acute Ischemic Stroke due to Large Vessel Occlusions (Pulse‐C Study)

Background and aims The first‐pass effect (FPE) is associated with improved clinical outcomes in mechanical thrombectomy (MT) for large vessel occlusion strokes (LVOS). However, current devices achieve FPE in only 30‐40% of patients. The RapidPulse® Aspiration System (RP) is designed to remove occlusive thrombus from the cerebral vasculature using precisely pulsed aspiration. The system aims to improve revascularization results during aspiration thrombectomy in patients with acute ischemic stroke. Initial clinical evaluation suggests that RapidPulse® can achieve FPE rates in the 70% range. Our goal is to evaluate this technology as a frontline approach in LVOS. Methods Prospective, multicenter, open‐label, early experience study of the RapidPulse® System. Patients with LVOS involving anterior and/or posterior circulations within 24 hours from stroke onset, without evidence of intracranial atherosclerotic disease and/or tandem occlusions, and amenable to treatment with the RapidPulse 071 aspiration catheter were eligible. The primary outcome was the rate of FPE (mTICI ≥2c after one pass). Secondary outcomes included frontline technical success (mTICI ≥2b after final pass with no rescue therapy), and incidence of vessel injury and/or device related SAEs. The study will enroll up to 50 participants at up to 5 centers in Europe and Latin America. Results As of August 2024, ten patients have been recruited and enrollment is expected to be completed in November 2024. The results of the study will be presented at the SVIN conference. Conclusions The RapidPulse® system is a novel cyclic aspiration technology designed to achieve faster and better reperfusion in LVOS while significantly improving FPE and frontline success rates which, in turn, may improve clinical outcomes and reduce overall procedure costs. Additional larger studies are underway.