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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 verify the noninferiority of the developed Jasper intracranial electrolytically detachable coil in the clinical application of embolized intracranial aneurysms. Method test for the prospective, multicenter parallel controlled clinical trial, the program approved by the State Drug Administration. A total of 134 patients with Hunt-Hess grade-0 to grade III non-wide-necked intracranial aneurysms were enrolled. Sixty-four patients in the Jasper coil (test group) were treated with an electrovapable detachable coil (GDC) and Sapphire coil (control group) example. Evaluate the clinical performance of the coil (the convenience and reliability of the delivery, positioning, release and retraction of the delivery system) and the success rate of the implantation during the operation. The Rankin score was improved at 1,6 months after operation. The results of immediate and 6-month postoperative angiography were assessed. The incidence of adverse events, again subarachnoid hemorrhage, death and stroke were observed. Results ① A total of 345 Jasper coils were used in the experimental group, with a success rate of 99.3% (344/345). The control group was 100% (304/304). There was no significant difference in success rate and clinical performance between the two groups (P> 0.05). During the test, no complications such as coil detachment, vasospasm, thrombosis, aneurysm rupture, and perforation of blood vessels were observed in both groups. (2) There was no significant difference between the two groups in modified Rankin score, incidence of adverse events, subarachnoid hemorrhage, death and stroke again (P> 0.05). (3) Immediate occlusion of the experimental group showed aneurysm occlusion rate of 95.4 ± 6.4%, incomplete occlusion of 6 cases (9.4%) and complete occlusion of 58 cases (90.6%). The occlusion rate of the aneurysm in the control group was 94.8 ± 5.5%), incomplete occlusion in 5 cases (7.1%) and complete occlusion in 65 cases (92.9%). There was no significant difference between the two groups (P> 0.05). ④ The experimental group 40 cases and the control group 32 cases were 6 months after angiography follow-up. There was no significant difference in occlusion rate between two groups (P> 0.05). Conclusion The application of Jasper intracranial electrolytic detachable coil in the treatment of intracranial aneurysms has the same clinical safety and efficacy as the mature products of the same kind in foreign countries.