FloWise Flow Diverter for Treatment of Unruptured Wide-Neck Intracranial Aneurysms: A Prospective, Multicenter, Single-Arm, Open-Label, Pivotal Study.

IF 4.4 2区医学 Q1 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING

Korean Journal of Radiology Pub Date : 2025-06-13 DOI:10.3348/kjr.2024.1212

Hyun Jin Han, Keun Young Park, Byung Moon Kim, Yong Bae Kim, Hong-Jun Jeon, Sang Hyun Suh, Sangil Suh, Jung-Jae Kim, Jun-Hwee Kim, Chang Ki Jang, Dong Joon Kim, Jung Keun Lee, Sunghan Kim, Kyu Seon Chung, Solbi Kim, Sun Yoon, Min Jeoung Kim

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引用次数: 0

Abstract

Objective: We evaluated the safety and efficacy of a new flow diverter in the treatment of unruptured wide-neck aneurysms.

Materials and methods: Patients who had unruptured intracranial aneurysms with a neck diameter ≥4 mm or dome-to-neck ratio <2 and who met other eligibility criteria were enrolled from seven institutions. The patients were treated with a new flow diverter (FloWise; Taewoong Medical, Seoul, Korea) and followed at 1, 3, 6, and 12 months after treatment. The primary efficacy endpoint was the complete occlusion of the target aneurysm at 12 months. Safety endpoints included ipsilateral stroke (National Institutes of Health Stroke Scale score ≥5), newly developed neurological deficit (modified Rankin Scale score ≥3), death at 30 days, and ≥50% parent artery stenosis or occlusion at the 12-month follow-up. The superiority of FloWise over the predefined reference value (56.7%) was investigated using a one-sided binomial test with a statistical significance of P < 0.025.

Results: Seventy patients (59.0 ± 9.9 years; male:female = 16:54) with 93 aneurysms (median diameter, 5.2 mm [range, 1.6-26.1 mm]; median neck diameter, 4.1 mm [range, 1.2-22.4 mm]) were included. Of these, 69 patients who completed the follow-up as planned constituted the efficacy analysis set. Complete aneurysm occlusion was achieved in 56 target aneurysms (81.2%; 95% confidence interval [CI], 69.9-89.6; P < 0.001). Procedural success and ≥50% aneurysm volume reduction were observed in 69 (100%) and 66 (95.7%; 95% CI, 87.8-99.1) target aneurysms, respectively. No ipsilateral strokes occurred in any of the 70 patients. Serious adverse events occurred in 6 patients; these events were causally related to the treatment in 4 (5.7%) cases and possibly related to the device in 2 (2.9%) cases.

Conclusion: FloWise flow diverter is safe and effective for the treatment of unruptured wide-neck aneurysms.

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FloWise分流器治疗未破裂的宽颈颅内动脉瘤：一项前瞻性、多中心、单臂、开放标签、关键研究。

目的：评价一种新型血流分流器治疗未破裂宽颈动脉瘤的安全性和有效性。材料和方法：颈直径≥4mm或颅圆颈比P < 0.025的未破裂颅内动脉瘤患者。结果：70例患者(59.0±9.9岁；男：女= 16:54)，动脉瘤93例(中位直径5.2 mm[范围1.6 ~ 26.1 mm]；中位颈径4.1 mm[范围1.2-22.4 mm])。其中，按计划完成随访的69例患者构成疗效分析集。56例靶动脉瘤完全闭塞(81.2%；95%置信区间[CI]， 69.9-89.6；P < 0.001)。69例（100%）和66例（95.7%）手术成功，动脉瘤体积缩小≥50%；95% CI分别为87.8 ~ 99.1)。70例患者均未发生同侧脑卒中。6例发生严重不良事件；4例（5.7%）与治疗有因果关系，2例（2.9%）可能与器械有关。结论：流动分流术治疗未破裂宽颈动脉瘤安全有效。

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

Korean Journal of Radiology 医学-核医学

CiteScore

10.60

自引率

12.50%

发文量

141

审稿时长

1.3 months

期刊介绍： The inaugural issue of the Korean J Radiol came out in March 2000. Our journal aims to produce and propagate knowledge on radiologic imaging and related sciences. A unique feature of the articles published in the Journal will be their reflection of global trends in radiology combined with an East-Asian perspective. Geographic differences in disease prevalence will be reflected in the contents of papers, and this will serve to enrich our body of knowledge. World''s outstanding radiologists from many countries are serving as editorial board of our journal.