학술논문
RapidpulseTMcyclic aspiration system for acute ischemic stroke due to large vessel occlusions
Document Type
Article
Author
Bajrami, Arsida; Geyik, Serdar; Ertugrul, Ozgur; Erdem, Eren; Gallego Leon, Jose I; Barbieri, Giorgio; Dominguez Rodriguez, Carlos; Rayón-Aledo, Jose Carlos; Barra, Antonio I Sagredo; Blanco, Fernando S Sanchez; Candel, Carmen Serna; Montalverne, Francisco Jose; Andrade, Lidemarcks I; Bandeira, Diego; Bezerra, Jose; Carm, Hellen; Silva, Henrique Coelho; Braga Cruz Guedes de Morais, Alessandra; de Lucena, Adson Freitas; Lima, Fabricio O; Mendes, George; Rocha, Felipe A; Kupcs, Karlis; Kidikas, Helmuts; Vetra, Janis; Gal, Gyula; Diaz, Anabel; Nogueira, Raul G
Source
Interventional Neuroradiology; 20240101, Issue: Preprints
Subject
Language
ISSN
15910199; 23852011
Abstract
Background The best strategy to achieve optimal reperfusion outcomes during mechanical thrombectomy remains to be defined. The RapidPulseTMCyclic Aspiration System is a novel technology, delivering high-frequency pulsed vacuum forces to increase the efficiency of aspiration thrombectomy.Methods Prospective, multicenter, open-label, core lab-adjudicated, two-arm study comparing safety and efficacy of a feasibility version of the RapidPulseTMsystem compared with contemporary controls. Primary endpoint was the rate of mTICI ≥ 2c after first-pass effect (FPE). Additional efficacy endpoints were the rates of mTICI ≥2b after first pass (modified FPE (mFPE)), last pass with study device defined as frontline technical success, and after all passes including rescue therapy. The primary safety endpoints included symptomatic ICH (sICH) within 24 h post-procedure.Results Between February 2022 to December 2022, 80 subjects were consented and enrolled in the study (n = 40 treatment arm, n = 40 control arm). In the intent to treat (ITT) population, mean age was 67.8 ± 11.5 years; 19 (47.5%) were male. Median NIHSS score was 16 (IQR: 13–22). Median ASPECTS score was 9 (IQR: 8–10). The rate of mTICI ≥ 2c after first pass was 53.9% in ITT population (60.0% in per-protocol population) versus 38.5% in the corresponding control population. Functional independence (mRS 0-2) at 90 days was achieved in 61.1% (22/36) in the RapidPulseTMarm and 52.8% (19/36) in the control arm. In the RapidPulseTMarm, no sICH within 24 h and no device-related morbidity or mortality occurred.Conclusion Preliminary data suggests RapidPulseTMAspiration System is highly effective and safe for recanalization of large vessel occlusions.