BackgroundThe best strategy to achieve optimal reperfusion outcomes during mechanical thrombectomy remains to be defined. The RapidPulseTM Cyclic Aspiration System is a novel technology, delivering high-frequency pulsed vacuum forces to increase the efficiency of aspiration thrombectomy.MethodsProspective, multicenter, open-label, core lab-adjudicated, two-arm study comparing safety and efficacy of a feasibility version of the RapidPulseTM 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 [Formula: see text] 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.ResultsBetween 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 RapidPulseTM arm and 52.8% (19/36) in the control arm. In the RapidPulseTM arm, no sICH within 24 h and no device-related morbidity or mortality occurred.ConclusionPreliminary data suggests RapidPulseTM Aspiration System is highly effective and safe for recanalization of large vessel occlusions.

中文翻译：

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RapidpulseTM 循环抽吸系统治疗大血管闭塞引起的急性缺血性中风

背景机械血栓切除术期间实现最佳再灌注结果的最佳策略仍有待确定。快速脉搏TM值循环抽吸系统是一项新技术，可提供高频脉冲真空力，以提高抽吸血栓切除术的效率。方法前瞻性、多中心、开放标签、核心实验室裁定的双臂研究比较了可行性版本的安全性和有效性快速脉冲TM值系统与当代控制系统的比较。主要终点是首过效应 (FPE) 后 mTICI ≥ 2c 的发生率。其他疗效终点是首次通过（改良 FPE (mFPE)）、使用研究设备的最后一次通过（定义为一线技术成功）以及所有通过（包括救援治疗）后的 mTICI 率 [公式：参见文本] 2b。主要安全终点包括术后 24 小时内的症状性脑出血 (sICH)。 结果 2022 年 2 月至 2022 年 12 月期间，80 名受试者同意并参加该研究（n = 40 治疗组，n = 40 对照组）。在意向治疗 (ITT) 人群中，平均年龄为 67.8 ± 11.5 岁； 19 名（47.5%）为男性。 NIHSS 评分中位数为 16（IQR：13-22）。 ASPECTS 得分中位数为 9（IQR：8-10）。首次通过后 mTICI ≥ 2c 的比率在 ITT 人群中为 53.9%（在符合方案人群中为 60.0%），而在相应的对照人群中为 38.5%。 90 天时，RapidPulse 中的功能独立性 (mRS 0-2) 达到 61.1% (22/36)TM值臂和对照组为 52.8% (19/36)。在快速脉冲中TM值手臂，24 小时内没有发生 sICH，并且没有发生与设备相关的发病率或死亡率。结论初步数据表明 RapidPulseTM值抽吸系统对于大血管闭塞的再通非常有效且安全。