Randomized, prospective, multicenter trial assessing the numen coil embolization system in the endovascular treatment of small intracranial aneurysms: outcomes from the CATCH Trial

• Published in: BMC surgery Vol. 23; no. 1; p. 164
• Main Authors: Jin, Yazhou, Guo, Xinbin, Quan, Tao, Zhao, Rui, Li, Tianxiao, Zhao, Zhenwei, Yang, Hua, Zhu, Xingen, Liang, Guobiao, Leng, Bing, Wu, Xin, Wang, Yang, Guan, Sheng
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 16.06.2023; BioMed Central; BMC
• Subjects: Analysis; Aneurysm; Aneurysms; Cardiovascular system; Care and treatment; Cerebral Angiography; Clinical trials; Complications; Embolization; Embolization, Therapeutic; Endovascular coiling; Endovascular treatment; Follow-Up Studies; Humans; Intracranial Aneurysm - therapy; Laboratories; Medical imaging; Medical research; Medicine, Experimental; Mortality; Numen Coil Embolization System; Occlusion; Patients; Prospective Studies; Safety; Small intracranial aneurysms; Stents; Treatment Outcome; China; Endovascular treatment; Numen Coil Embolization System; Small intracranial aneurysms
• ISSN: 1471-2482; 1471-2482
• DOI: 10.1186/s12893-023-02049-9

The CATCH (Coil Application Trial in China) trial was designed to assess the safety and efficacy of the Numen Coil Embolization System in the treatment of intracranial aneurysms in comparison with the Axium coil (ev3/Medtronic). Although the endovascular treatment of small (< 5 mm) intracranial aneurysms has been reported with favorable long-term clinical and angiographic outcomes, randomized trials are still lacking. Data for aneurysms smaller than 5 mm were extracted from the CATCH trial. A randomized, prospective, multicenter trial was conducted at ten centers throughout China. Enrolled subjects with small intracranial aneurysms were randomly assigned to receive treatment with the Numen Coil or the Axium coil. The primary outcome was successful aneurysm occlusion at the 6-month follow-up. In contrast, the secondary outcomes included complete aneurysm occlusion, recurrence rate, clinical deterioration, and safety data at the 6-month and 12-month follow-ups. A total of 124 patients were enrolled in the study. Overall, 58 patients were assigned to the Numen group, and 66 were assigned to the Axium group. At the 6-month follow-up, the successful aneurysm occlusion rate was 93.1% (54/58) in the MicroPort NeuroTech group and 97.0% (64/66) in the Axium group, with a common odds ratio of 0.208 (95% confidence interval, 0.023-1.914; P = 0.184). Complications were comparable between the groups. Compared with the Aixum coil, the Numen coil is safe and effective in treating small intracranial aneurysms. (13/12/2016, NCT02990156).