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

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。

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

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.