Endovascular Aneurysm Treatment with the Numen Coil Embolization System: A Prospective Randomized Controlled Open-Label Multicenter Noninferiority Trial in China.

Abstract

OBJECTIVE:

We investigated the safety and efficacy of the Numen coil compared with the Axium coil in the treatment of intracranial aneurysms.

METHODS:

Because CATCH (Coil Application Trial in China) is a prospective randomized controlled open-label noninferiority trial conducted in 10 centers across China, patients who fulfilled the inclusion and exclusion criteria were randomized 1:1 to either a test group (Numen) or a control group (Axium). The primary outcome was based on successful aneurysm occlusion at 6 months follow-up, whereas secondary outcomes included technical success, the recanalization and retreatment rates, and the rate of serious adverse events (SAEs) at 6 months and 12 months follow-up.

RESULTS:

Between August 2017 and December 2019, 350 patients presenting with 350 aneurysms were enrolled and randomized. Per-protocol analysis showed that the successful aneurysm occlusion rate at 6 months was 91.18% for the test group compared with 91.85% in the control group, with a difference of -0.68% (P = 0.8419), and the overall mortality during the 30-day follow-up period was 1.19% and 1.81% in the test and control group, respectively, showing no significant difference between the 2 groups (P = 0.6837), whereas the SAE incidence during the 12-month follow-up period was 12.50% and 17.47% in the test and control groups, respectively, which was not statistically significant (P = 0.2222).

CONCLUSIONS:

This trial showed that the Numen coil was noninferior to the Axium coil in terms of intracranial aneurysm embolization and can be considered as a safe and effective coil for treating patients with intracranial aneurysm in clinical practice.

• Authors: Rui Zhao, Guoli Duan, Pengfei Yang, Tianxiao Li, Sheng Guan, Hua Yang, Zhenwei Zhao, Xingen Zhu, Guobiao Liang, Xin Wu, Bing Leng, Yang Wang, Yina Wu, Qiao Zuo, Lei Zhang, ZiFu Li, Yu Zhou, Kaijun Zhao, Dongwei Dai, Yibin Fang, Qiang Li, Qinghai Huang, Bo Hong, Yi Xu, Jianmin Liu, CATCH Investigators, Zhang Kaixia, Chen Gong, Ann Qingzhu, Zheng Yongtao, He Yingkun, Bai Weixing, Lei Zhang, Kang Xiaoyu, Wang Ning, Guan Min, Xu Bin, Duan Guangming, Li Li, Zhu Liangfu, Zhou Zhilong, Shao Qiuji, Chang Kaitao, Wu Liheng, Li Qiang, Gu Jianjun, Zhang Kun, Wang Yongfeng, Zhao Zhiyu, Chen Zhen, Xu Haowen, Wang Linyu, Guo Xinbin, Liu Chao, Fang Feng, Liu Zining, Guo Yuanyuan, Chen Hu, Yan Zhongjun, Fang Wei, Lu Wenyan, Li Jiang, Deng Jianping, Li Zhihong, Gao Xu, Wang Xiaogang, Dong Yushu, Li Chuangzhong, Liu Song, Teng Lu, Yuan Yuan, Shang Minghua, Zhang Zaiqiang, Wang Jing, Sang Guifeng, Cheng Jiyong, Zhang Zhen, Zhou Xiaobing, Chen Yan, Lai Lingfeng, Dong Youqing, Mao Guohua, Zhu Jianming, Lai Xianliang, Gao Ziyun, Song Shuxin, Ye Minhua, Fan Yijin, Xiang Xin, Peng Han, Yan Jian, Fang Wenting
• Journal: World neurosurgery (World Neurosurg) Vol. 160 Pg. e23-e32 (04 2022) ISSN: 1878-8769 [Electronic] United States
• PMID: 34906756 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2021 Elsevier Inc. All rights reserved.

Topics

• Aortic Aneurysm, Abdominal
• Blood Vessel Prosthesis Implantation
• Embolization, Therapeutic (methods)
• Endovascular Procedures (methods)
• Follow-Up Studies
• Humans
• Intracranial Aneurysm (etiology, surgery)
• Prospective Studies
• Treatment Outcome