国产血流导向装置Repath治疗颅内动脉瘤的安全性及有效性研究

Safety and efficiency of domestic flow diverter Repath in the treatment of intracranial aneurysms

目的初步探讨国产血流导向装置Repath治疗颅内动脉瘤的安全性及有效性。方法本研究为前瞻性、单中心、单臂临床前期试验,共纳入10例颅内动脉瘤患者并完成Repath血流导向装置植入,描述性分析Repath支架植入技术成功率、手术并发症及6个月动脉瘤闭塞率。结果 10例颅内动脉瘤患者(13个动脉瘤)纳入本研究,共植入11枚Repath血流导向装置,Repath支架植入技术成功率100%。术后1个月、3个月、6个月随访,除1例无症状性脑梗死外无器械及责任血管相关不良事件,9例患者完成6个月影像学随访,动脉瘤闭塞率75%(9/12动脉瘤)。结论血流导向装置Repath在治疗颅内动脉瘤中具有较高的安全性及有效性,但仍需大型、多中心、随机对照研究进一步证实。

Objective To explore the safety and efficiency of domestic flow diverter Repath in the treatment of intracranial aneurysms.Methods This is a prospective,single center,single arm preclinical study.A total of 10 patients with intracranial aneurysms and treated with Repath stent were enrolled in this study.The technical success rate,procedure complication and 6-month aneurysm occlusion rate were analyzed.Results Ten patients with 13 intracranial aneurysms were enrolled and 11 Repath stent were successfully planted in this study.Nine patients accomplished 6-month angiographic follow-up.The technical success rate of sent plantation was 100%,one patient had asymptotic infarction after procedure.The 1-,3-and 6-month follow-up indicated no stent-related complication.Conclusion This study indicated that Repath flow diverter is safe and effective in the treatment of intracranial aneurysms,but need further large,multi-center random controlled study to confirm.