• World Neurosurg · May 2024

    Randomized Controlled Trial Multicenter Study

    Gekko coil system for intRacranial anEurysms treATment in China (GREAT-China): A prospective randomized controlled open-label non-inferiority trial.

    • Guoli Duan, Yuhang Zhang, Qiang Li, Pengfei Yang, Jianmin Zhang, Honglei Wang, Jun Ma, Sheng Guan, Zhian Han, Hua Yang, Haibin Shi, Yunhui Liu, Chuansheng Liang, Xin Wu, Yina Wu, Qiao Zuo, Zhengzhe Feng, Lei Zhang, ZiFu Li, Yu Zhou, Dongwei Dai, Yibin Fang, Qinghai Huang, Yi Xu, Rui Zhao, Jianmin Liu, and GREAT-China Investigators.
    • Department of Neurovascular Center, The First Affiliated Hospital of Naval Medical University, Shanghai, China.
    • World Neurosurg. 2024 May 1; 185: 181192181-192.

    ObjectiveThis study aimed to evaluate the safety and efficacy of the Gekko coil system in treating intracranial aneurysms (IAs) in clinical practice.MethodsA prospective multicenter randomized open-label parallel positive control noninferiority trial was conducted by 11 centers in China. Patients with a target IA were randomized 1:1 to coiling with either Gekko or Axium coils. The primary outcome was successful aneurysm occlusion at 6 months postoperative follow-up, whereas the secondary outcomes included the successful occlusion aneurysm rate in the immediate postoperative period, recanalization rate at the 6 months follow-up, and technical success and security.ResultsBetween May 2018 and September 2020, 256 patients were enrolled and randomized. Per-protocol analysis showed that the successful aneurysm occlusion rate at 6 months was 96.08% for the Gekko coil group compared with 96.12% in the Axium coil group, with a difference of -0.04% (P = 0.877). The successful immediate aneurysm occlusion rates were 86.00% and 77.45% in the Gekko coil group and the Axium coil group, respectively, showing no significant difference between the 2 groups (P = 0.116), whereas the recanalization rates during the 6 months follow-up were 2.02% and 1.96% in the Gekko and Axium coil groups, respectively, which was not statistically significant (P = 1.000).ConclusionsThis trial showed that the Gekko coil system was noninferior to the Axium coil system in terms of efficacy and safety for IA embolization. In clinical practice, the Gekko coil system can be considered safe and effective for treating patients with IA.Copyright © 2024 Elsevier Inc. All rights reserved.

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