Abstract WMP96: A Prospective Trial Of The Rapidpulse ^Tm Aspiration System As Frontline Approach For Stroke Thrombectomy (RapidPulseFS)

Abstract

Introduction: First-pass effect (FPE) is associated with improved clinical outcomes and reduced mortality in mechanical thrombectomy (MT) for large vessel occlusion strokes (LVOS). However, FPE is achieved in only 30-40% of patients with the current devices. The RapidPulse TM Cyclic Aspiration System (RP) is a novel technology consisting of a valve box that precisely cycles pressure from full to no vacuum multiple times per second adding kinetic energy to the suction forces. Initial clinical evaluation suggests that the system can achieve FPE rates in the 70% range. We aim to evaluate the RP as a frontline approach in LVOS. Methods: Prospective, multicenter, open-label, core lab adjudicated, two-arm study comparing the safety and efficacy of the RP System with non-randomized retrospective controls who were consecutively treated at the study sites based on similar eligibility criteria. Patients with LVOS involving the anterior or posterior circulations in whom the target lesion could be treated with the Medtronic React 71 aspiration catheter up to 24 hours from stroke onset were included in the RP arm. Controls consisted of comparable patients treated with 070-072 ID catheters. The primary outcome was the rate of FPE (complete/near reperfusion [mTICI ≥2c] after a single pass). Secondary outcomes include frontline technical success (defined as mTICI ≥2b after final device pass with no rescue therapy), final mTICI after all passes, symptomatic ICH, device-related complications, the proportion of patients achieving a modified Rankin Scale score of 0-2 at 90 days, and all-cause 90-day mortality. The study will enroll a maximum of 100 participants in the RP and 200 in the control arm at 5 centers in Spain, Turkey, Denmark, Latvia, and Brazil. Results: Final results will be presented at the conference. Conclusion: RapidPulseFS is the first prospective clinical trial aiming to compare cyclic versus standard aspiration technologies. This novel device may allow clinicians to achieve faster and better reperfusion while significantly reducing the disposable device costs associated with treating LVOS (ClinicalTrials.gov Identifier: NCT05122637).