目的:大血管腔内治疗,通过线圈栓塞的颅内宽颈动脉瘤通常由于完全闭塞率低和复发率高而复杂化。已证明分流器装置不仅可以安全有效地治疗大型和巨大的未破裂动脉瘤,而是中小型动脉瘤。然而,在韩国,直到最近才被批准用于<10mm的动脉瘤。本研究旨在比较血流分流和弹簧圈栓塞治疗≥7mm未破裂动脉瘤的安全性和有效性。
方法:参与者将包括年龄在19至75岁之间的患者,这些患者首次接受未破裂脑动脉瘤≥7mm的治疗或初次血管内线圈栓塞后复发动脉瘤的治疗。分配到分流队列的参与者将使用以下任何设备进行治疗:带有屏蔽技术的管道柔性栓塞设备(Medtronic,明尼阿波利斯,MN,美国),SurpassEvolve(Stryker神经血管,弗里蒙特,CA,美国),和FRED或FREDJr.(微风,Tustin,CA,美国)。分配到线圈栓塞队列的参与者将接受传统的血管内线圈。主要终点将是在治疗后12个月通过脑血管造影证实的完全闭塞。次要安全性结果将评估围手术期和术后并发症长达12个月。
结果:该试验将于2022年开始注册,并在注册和随访后提供临床数据。
结论:本文描述了多中心的目标和设计,随机化,开放标签试验比较血流分流术与传统血管内治疗≥7mm未破裂脑动脉瘤的安全性和疗效.
OBJECTIVE: Endovascular treatment of large, wide-necked intracranial aneurysms by coil embolization is often complicated by low rates of complete occlusion and high rates of recurrence. A flow diverter device has been shown to be safe and effective for the treatment of not only large and giant unruptured aneurysms, but small and medium aneurysms. However, in Korea, its use has only recently been approved for aneurysms <10 mm. This
study aims to compare the safety and efficacy of flow diversion and coil embolization for the treatment of unruptured aneurysms ≥7 mm.
METHODS: The participants will include patients aged between 19 and 75 years to be treated for unruptured cerebral aneurysms ≥7 mm for the first time or for recurrent aneurysms after initial endovascular coil embolization. Participants assigned to a flow diversion cohort will be treated using any of the following devices : Pipeline Flex Embolization Device with Shield Technology (Medtronic, Minneapolis, MN, USA), Surpass Evolve (Stryker Neurovascular, Fremont, CA, USA), and FRED or FRED Jr. (MicroVention, Tustin, CA, USA). Participants assigned to a coil embolization cohort will undergo traditional endovascular coiling. The primary endpoint will be complete occlusion confirmed by cerebral angiography at 12 months after treatment. Secondary safety outcomes will evaluate periprocedural and post-procedural complications for up to 12 months.
RESULTS: The
trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up.
CONCLUSIONS: This article describes the aim and design of a multi-center, randomized, open-label
trial to compare the safety and efficacy of flow diversion versus traditional endovascular treatment for unruptured cerebral aneurysms ≥7 mm.