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在内动脉瘤治疗中使用水凝卷:一个多中心,前性,随机的开放标签试验
Hirotoshi Imamura1, Nobuyuki Sakai1, Chiaki Sakai1
11Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe.
Journal of neurosurgery
|January 17, 2025
概括
第二代凝涂层线圈 (HGCs) 在脑动脉瘤治疗中,与裸线圈 (BPCs) 相比,并没有显著降低再通道化率. 然而,HGCs显示出增加血栓形成和减少再通道化的趋势.
科学领域:
- 干预性神经辐射学
- 医疗器械中的生物材料
- 血管外科 血管外科
背景情况:
- 水凝涂层线圈 (HGCs) 在减少再通道化和提高脑动脉瘤治疗的安全性方面表现有前途.
- 第二代HGCs的开发旨在进一步增强这些益处,需要进一步的临床评估.
研究的目的:
- 评估第二代凝涂层线圈 (HGC) 在预防脑动脉瘤再通道化的有效性.
- 为了比较HGCs的重新道化率和安全概况与裸线圈 (BPCs).
主要方法:
- 一项随机对照试验 (HYBRID试验) 涉及43个日本机构的432名患者.
- 第二代HGC与裸卷 (BPC) 的比较,用于测量7-20毫米的动脉瘤.
- 主要终点:通过核心实验室评估评估,在栓塞后1年重新道化率.
主要成果:
- 在HGCs (3.3%) 和BPCs (7.1%) (p=0.083) 之间,整体再通道化率没有统计学上显著的差异.
- 在1年内在HGC组观察到显著更多的血栓形成和较少的再通道化 (p=0.043).
- 与BPC手臂 (6.6%) (p=0.036) 相比,HGC手臂 (2.3%) 的重大再通道化率明显较低.
结论:
- 与BPC相比,第二代HGCs没有显示出与BPC相比,重新道化率的统计显著降低.
- 在中等大小的大脑动脉瘤中,HGCs可能会促进血栓形成的增加和减少再通道化.
- 临床试验注册:UMIN000006748.8. 临床试验注册:UMIN000006748. 临床试验注册:UMIN000006748. 临床试验注册: 临床试验注册: 临床试验注册: 临床试验注册: 临床试验注册
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