Rapidpulse^TM cyclic aspiration system for acute ischemic stroke due to large vessel occlusions.

IF 1.5 4区医学 Q4 CLINICAL NEUROLOGY Interventional Neuroradiology Pub Date : 2024-03-22 DOI:10.1177/15910199241239094

Arsida Bajrami, Serdar Geyik, Ozgur Ertugrul, Eren Erdem, Jose I Gallego Leon, Giorgio Barbieri, Carlos Dominguez Rodriguez, Jose Carlos Rayón-Aledo, Antonio I Sagredo Barra, Fernando S Sanchez Blanco, Carmen Serna Candel, Francisco Jose Montalverne, Lidemarcks I Andrade, Diego Bandeira, Jose Bezerra, Hellen Carm, Henrique Coelho Silva, Alessandra Braga Cruz Guedes de Morais, Adson Freitas de Lucena, Fabricio O Lima, George Mendes, Felipe A Rocha, Karlis Kupcs, Helmuts Kidikas, Janis Vetra, Gyula Gal, Anabel Diaz, Raul G Nogueira

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引用次数: 0

Abstract

Background: The best strategy to achieve optimal reperfusion outcomes during mechanical thrombectomy remains to be defined. The RapidPulse^TM Cyclic 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 RapidPulse^TM system 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 $\geq$ 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 RapidPulse^TM arm and 52.8% (19/36) in the control arm. In the RapidPulse^TM arm, no sICH within 24 h and no device-related morbidity or mortality occurred.

Conclusion: Preliminary data suggests RapidPulse^TM Aspiration System is highly effective and safe for recanalization of large vessel occlusions.

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RapidpulseTM 循环抽吸系统，用于治疗大血管闭塞导致的急性缺血性中风。

背景：在机械血栓切除术中实现最佳再灌注效果的最佳策略仍有待确定。RapidPulseTM 循环抽吸系统是一项新技术，可提供高频脉冲真空力，提高抽吸血栓切除术的效率：方法：前瞻性、多中心、开放标签、核心实验室判断、双臂研究，比较 RapidPulseTM 系统可行性版本与当代对照组的安全性和有效性。主要终点是首过效应（FPE）后 mTICI ≥ 2c 的比率。其他疗效终点为首次通气（改良 FPE (mFPE)）后 mTICI ≥ 2b 的比率、使用研究设备的最后一次通气（定义为前线技术成功）以及所有通气（包括抢救治疗）后的 mTICI ≥ 2b 的比率。主要安全性终点包括术后24小时内的无症状ICH（sICH）：2022年2月至2022年12月，80名受试者同意并加入研究（治疗组40人，对照组40人）。在意向治疗（ITT）人群中，平均年龄为（67.8 ± 11.5）岁；19 名男性（47.5%）。NIHSS 评分中位数为 16（IQR：13-22）。ASPECTS 评分中位数为 9（IQR：8-10）。首次通过后，mTICI ≥ 2c 的比例在 ITT 群体中为 53.9%（在按协议人群中为 60.0%），而在相应的对照人群中为 38.5%。RapidPulseTM 治疗组有 61.1%（22/36）的患者在 90 天后实现了功能独立（mRS 0-2），对照组有 52.8%（19/36）的患者实现了功能独立（mRS 0-2）。RapidPulseTM治疗组在24小时内没有发生sICH，也没有发生与设备相关的发病或死亡：初步数据表明，RapidPulseTM 抽吸系统对大血管闭塞的再通术非常有效且安全。

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来源期刊

Interventional Neuroradiology CLINICAL NEUROLOGY-RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING

CiteScore

3.60

自引率

11.80%

发文量

192

审稿时长

6-12 weeks

期刊介绍： Interventional Neuroradiology (INR) is a peer-reviewed clinical practice journal documenting the current state of interventional neuroradiology worldwide. INR publishes original clinical observations, descriptions of new techniques or procedures, case reports, and articles on the ethical and social aspects of related health care. Original research published in INR is related to the practice of interventional neuroradiology...