Jasper电解可脱性弹簧圈治疗颅内动脉瘤的多中心临床试验研究

Jasper Guglielmi detachable coil embolization of intracranial aneurysms:a multicenter clinical trial

目的验证国内研发的Jasper颅内电解可脱性弹簧圈在栓塞颅内动脉瘤临床应用中的非劣效性。方法试验为前瞻性、多中心平行对照临床试验,方案由国家药品监督管理局审定。选择Hunt-Hess0～Ⅲ级的非宽颈颅内动脉瘤患者134例,其中使用Jasper弹簧圈(试验组)64例,使用电解可脱性弹簧圈(GDC)和Sapphire弹簧圈(对照组)70例。评估手术操作过程中,弹簧圈的临床性能(输送系统推送、定位、释放和回撤等操作的方便性与可靠性)及置入的成功率;术后1、6个月行改良Rankin评分;对术后即刻和6个月的造影结果进行评定;观察不良事件发生、再次蛛网膜下腔出血、死亡和卒中的发生率。结果①试验组共使用345枚Jasper弹簧圈,置入成功率为99.3%(344/345)。对照组为100%(304/304),两组弹簧圈的置入成功率和临床性能的比较差异均无统计学意义(P>0.05)。在试验过程中,两组均未出现弹簧圈脱落、血管痉挛、血栓形成、动脉瘤破裂、血管穿孔等并发症。②改良Rankin评分、不良事件发生率、再次蛛网膜下腔出血、死亡和卒中发生率两组比较,差异均无统计学意义(P>0.05)。③试验组术后即刻造影显示动脉瘤闭塞率为(95.4±6.4)%,不完全闭塞6例(9.4%),完全闭塞58例(90.6%);对照组术后动脉瘤闭塞率为(94.8±5.5)%,不完全闭塞5例(7.1%),完全闭塞65例(92.9%),两组比较差异均无统计学意义(P>0.05)。④试验组40例和对照组32例术后6个月获得血管造影随访。动脉瘤闭塞率两组差异无统计学意义(P>0.05)。结论应用Jasper颅内电解可脱性弹簧圈治疗颅内动脉瘤,具有与目前国外同类成熟产品相同的临床安全性和有效性。

Objective To validate the non-inferiority of Jasper Guglielmi detachable coil （GDC） developed by Achieva Medical Co. Ltd （Shanghai, China） in the embolization of intracranial aneurysms in clinical practice.Methods It was a prospective, multicenter, parallel, comparative clinical trial, and the regimen was approved by the Chinese State Food and Drug Administration （SFDA）. A total 134 patients with non wide-necked intracranial aneurysms （Hunt-Hess grades 0-Ⅲ） were recruited. Among them, 64 patients used Jasper coils （trial group）, and 70 used GDC and Sapphire coils （control group）. The clinical performance of the coils （the convenience and reliability of the procedures in pushing, location releasing and withdrawing of delivery system） in the operation process and the success rate of implantation were evaluated during the procedures, the modified Rankin scale （mRS） scores were obtained at 1 and 6 months after the procedures, the results of angiography were assessed immediately after the procedures and at 6 months, the incidences such as the occurrence of adverse events, reoccurrence of subarachnoid hemorrhage, death and stroke were observed.Results The success rate of Jasper coil implantation in the trial group was 99.3% （344/345 coils）, and it was 100% （304/304 coils） in the control group. There were no significant differences between the two groups in the success rate of coil implantation and clinical performance （P〉0.05）. No complications such as coil dislodgement, vasospasm, thrombosis, aneurysm rupture and vascular perforation were found. There were no significant differences between the two groups in mRS scores, the incidence of adverse events, the reoccurrence of subarachnoid hemorrhage, death and stroke （P〉0.05）. Angiography showed that the occlusion rate of lesions was 95.4±6.4% immediately after the procedures in the trial group. Six patients （9.4%） had incomplete occlusion, and 58 （90.6%） had complete occlusion. The occlusion rate of lesions was 94.8±5.5% after the procedures in the control group. Five patients （7.1%） had incomplete occlusion, and 65 （92.9%） had complete occlusion. There were no significant differences between the two groups （P〉0.05）. The follow-up angiographies were obtained in 40 patients in the trial group and 32 in the control group 6 months after the procedures. There were no significant differences between the two groups in the occlusion rate of aneurysms （P〉0.05）.Conclusion The clinical safety and efficacy of Jasper GDC for embolization of intracranial aneurysms are the same as those of the foreign products.