Department of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Department of Neurosurgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Korean J Radiol. 2020 Feb;21(2):228-235. doi: 10.3348/kjr.2019.0188.
The Alpha stent (CGBio), a new intracranial stent featuring a re-sheathable mesh design with improved wall apposition at the curved segment, was clinically evaluated. We report the 6-month follow-up results from a prospective, single-center study in which the stent was used for coiling of wide-necked distal internal carotid artery (ICA) aneurysms.
Between April 2016 and 2018, 50 patients (mean age, 56.5 years, 45 females [90%]) with 54 unruptured distal ICA aneurysms (average diameter: 5.6 ± 1.7 mm) were enrolled. The primary endpoint for effectiveness was successful coil embolization with the Alpha stent, and subsequent complete or near-complete occlusion at the 6-month magnetic resonance angiography assessment. The primary safety endpoint was the absence of serious adverse events (SAEs) up to 6 months from the procedure.
The primary effectiveness endpoint was observed in 94.4% (51/54) aneurysms. In one patient with technical failure, the stent could not be deployed because of parent artery tortuosity; therefore, a different type of stent was used. Of the 53 aneurysms treated with the Alpha stent, complete occlusion was achieved in 64.1% (34/53) cases, and near-complete occlusion was achieved in 32.0% (17/53) cases by the 6-month follow-up. Two cases (3.7%) required retreatment because of major recurrence. In 4% (2/50) patients, SAEs, i.e., retinal artery thromboembolism and corona radiata lacunar infarction, were reported after the procedure.
For endovascular treatment of unruptured, wide-necked, distal ICA aneurysms, coil embolization using the newly developed Alpha stent showed excellent procedural and mid-term clinical follow-up results in terms of effectiveness and safety.
新型颅内支架 Alpha 支架（CGBio）采用可重新护套的网孔设计，在弯曲段具有更好的贴壁效果，已进行临床评估。我们报告了一项前瞻性、单中心研究的 6 个月随访结果，该研究中使用该支架对宽颈远端颈内动脉（ICA）动脉瘤进行线圈栓塞。
2016 年 4 月至 2018 年期间，50 例（平均年龄 56.5 岁，45 例女性[90%]）患有 54 个未破裂的远端 ICA 动脉瘤（平均直径：5.6±1.7mm）的患者入组。有效性的主要终点是 Alpha 支架成功栓塞线圈，并且在 6 个月的磁共振血管造影评估时完全或接近完全闭塞。主要安全性终点是在手术 6 个月内无严重不良事件（SAE）。
94.4%（51/54）的动脉瘤观察到主要有效性终点。在 1 例因母动脉迂曲导致技术失败的患者中，支架不能展开，因此使用了另一种类型的支架。在使用 Alpha 支架治疗的 53 个动脉瘤中，完全闭塞的比例为 64.1%（34/53），6 个月随访时接近完全闭塞的比例为 32.0%（17/53）。有 2 例（3.7%）因严重复发需要再次治疗。在 4%（2/50）的患者中，术后出现了 SAE，即视网膜动脉血栓栓塞和放射冠腔隙性脑梗死。
对于未破裂的宽颈、远端 ICA 动脉瘤的血管内治疗，使用新开发的 Alpha 支架进行线圈栓塞在有效性和安全性方面具有出色的手术和中期临床随访结果。
