1. Endovascular Aneurysm Treatment with the Numen Coil Embolization System: A Prospective Randomized Controlled Open-Label Multicenter Noninferiority Trial in China.
- Author
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Zhao, Rui, Duan, Guoli, Yang, Pengfei, Li, Tianxiao, Guan, Sheng, Yang, Hua, Zhao, Zhenwei, Zhu, Xingen, Liang, Guobiao, Wu, Xin, Leng, Bing, Wang, Yang, Wu, Yina, Zuo, Qiao, Zhang, Lei, Li, ZiFu, Zhou, Yu, Zhao, Kaijun, Dai, Dongwei, and Fang, Yibin
- Subjects
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INTRACRANIAL aneurysms , *ANEURYSMS , *CONTROL groups , *UTERINE artery , *THERAPEUTIC embolization - Abstract
We investigated the safety and efficacy of the Numen coil compared with the Axium coil in the treatment of intracranial aneurysms. 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. 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). 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. [ABSTRACT FROM AUTHOR]
- Published
- 2022
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