Multicenter clinical trial evaluating the safety and efficacy of mechanical thrombectomy using the Versi Retriever.

IF 4.5 1区医学 Q1 NEUROIMAGING

Journal of NeuroInterventional Surgery Pub Date : 2024-10-10 DOI:10.1136/jnis-2024-022207

Nobuyuki Ohara, Hirotoshi Imamura, Tetsu Satow, Hiroshi Yamagami, Shinichi Yoshimura, Nobutaka Horie, Akira Ishii, Toshiyuki Fujinaka, Yasushi Matsumoto, Tomoyuki Tsumoto, Shinya Kohyama, Yuji Matsumaru, Koji Iihara, Naoya Kuwayama, Teruyuki Hirano, Yasushi Ito, Haruko Yamamoto, Yoji Nagai, Chiaki Sakai, Nobuyuki Sakai

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引用次数: 0

Abstract

Background: This study aimed to elucidate the safety and efficacy of mechanical thrombectomy using the Versi Retriever in patients with acute ischemic stroke (AIS).

Methods: This was a prospective, multicenter, single-arm study conducted at 10 institutes in Japan from December 2018 to March 2021 on mechanical thrombectomy using the Versi Retriever in patients with AIS. The primary efficacy outcome was the modified Rankin scale (mRS) 0-2 at 90 days after the procedure. The primary safety outcome was mortality within 90 days after the procedure.

Results: Fifty-eight patients with a mean age of 72.7 years were enrolled in the study. The primary efficacy outcome of mRS 0-2 at 90 days was 62.0% (95% CI 47.2-75.3%) in patients within 8 hours of stroke onset. The rate of immediate reperfusion of Thrombolysis in Cerebral Infarction (TICI) grade 2b-3 using the Versi Retriever in three passes was 78.0% (64.0-88.5%). The rate of final reperfusion of TICI 2b-3 was 100% (92.9-100%). The primary safety outcome of mortality within 90 days was 8.0% (2.2-19.2%) in patients within 8 hours of AIS onset. The incidence of intracranial hemorrhage within 24 hours was 12.0% (4.5-24.3%) for symptomatic cases and 32.0% (19.5-46.7%) for asymptomatic cases.

Conclusion: The Versi Retriever proved to be a safe and effective option for mechanical thrombectomy in patients with AIS.

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评估使用 Versi Retriever 进行机械血栓切除术的安全性和有效性的多中心临床试验。

背景：本研究旨在阐明使用Versi Retriever对急性缺血性脑卒中（AIS）患者进行机械血栓切除术的安全性和有效性：本研究旨在阐明急性缺血性脑卒中（AIS）患者使用Versi Retriever进行机械血栓切除术的安全性和有效性：这是一项前瞻性、多中心、单臂研究，于2018年12月至2021年3月在日本的10家机构进行，研究对象是使用Versi Retriever对AIS患者进行机械血栓切除术。主要疗效指标为术后90天的改良Rankin量表（mRS）0-2。主要安全性指标为术后90天内的死亡率：研究共招募了 58 名患者，平均年龄为 72.7 岁。中风发生 8 小时内患者 90 天后 mRS 0-2 的主要疗效为 62.0%（95% CI 47.2-75.3%）。使用 Versi Retriever 三次治疗后，脑梗塞溶栓（TICI）2b-3 级患者的即刻再灌注率为 78.0% (64.0-88.5%)。TICI 2b-3 级的最终再灌注率为 100%（92.9%-100%）。AIS发生后8小时内患者90天内的死亡率为8.0%（2.2%-19.2%），这是主要的安全性结果。无症状病例在24小时内颅内出血的发生率为12.0%（4.5-24.3%），无症状病例为32.0%（19.5-46.7%）：结论：Versi Retriever被证明是AIS患者进行机械血栓切除术的一种安全有效的选择。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of NeuroInterventional Surgery NEUROIMAGING-SURGERY

CiteScore

9.50

自引率

14.60%

发文量

291

审稿时长

4-8 weeks

期刊介绍： The Journal of NeuroInterventional Surgery (JNIS) is a leading peer review journal for scientific research and literature pertaining to the field of neurointerventional surgery. The journal launch follows growing professional interest in neurointerventional techniques for the treatment of a range of neurological and vascular problems including stroke, aneurysms, brain tumors, and spinal compression.The journal is owned by SNIS and is also the official journal of the Interventional Chapter of the Australian and New Zealand Society of Neuroradiology (ANZSNR), the Canadian Interventional Neuro Group, the Hong Kong Neurological Society (HKNS) and the Neuroradiological Society of Taiwan.