Article Text
Abstract
Introduction First-pass effect (FPE) is associated with improved clinical outcomes 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™ Aspiration System (RP) is designed to remove occlusive thrombus from the cerebral vasculature using precisely pulsed aspiration. RapidPulse™ Aspiration System is intended to improve revascularization results during aspiration thrombectomy in patients with acute ischemic stroke. Initial clinical evaluation suggests that the system can achieve FPE rates in the 70% range.
Aim of Study We aim to evaluate the RP Aspiration System as a frontline approach in LVOS.
Methods Prospective, multicenter, open-label, early experience of the RapidPulseTM System. Patients with LVOS involving anterior and/or posterior circulations within 24 hours from stroke onset 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 vasospasm. The study will enroll up to 50 participants at 5 centers in Europe and Latin America
Results As of April 2024, one patient has been recruited and enrollment is expected to be completed by September 2024. Final results will be presented at the ESMINT.
Conclusion RapidPulse is a novel cyclic aspiration technology designed to achieve faster and better reperfusion in LVOS while significantly reducing disposable device costs. Additional larger studies are currently underway.
Disclosure of Interest yes Consultant for Rapid Pulse.