Background and Purpose:Stent-assisted coil embolization using the new generation Neuroform Atlas Stent System has shown promising safety and efficacy. The primary study results of the anterior circulation aneurysm cohort of the treatment of wide-neck, saccular, intracranial, aneurysms with the Neuroform Atlas Stent System (ATLAS trial [Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms With the Neuroform Atlas Stent System]) are presented.Methods:ATLAS IDE trial (Investigational Device Exemption) is a prospective, multicenter, single-arm, open-label study of wide-neck (neck ≥4 mm or dome-to-neck ratio <2) intracranial aneurysms in the anterior circulation treated with the Neuroform Atlas Stent and approved coils. The primary efficacy end point was complete aneurysm occlusion (Raymond-Roy class 1) on 12-month angiography, in the absence of retreatment or parent artery stenosis (>50%) at the target location. The primary safety end point was any major stroke or ipsilateral stroke or neurological death within 12 months. Adjudication of the primary end points was performed by an independent Imaging Core Laboratory and the Clinical Events Committee.Results:A total of 182 patients with wide-neck anterior circulation aneurysms at 25 US centers were enrolled. The mean age was 60.3±11.4 years, 73.1% (133/182) women, and 80.8% (147/182) white. Mean aneurysm size was 6.1±2.2 mm, mean neck width was 4.1±1.2 mm, and mean dome-to-neck ratio was 1.2±0.3. The most frequent aneurysm locations were the anterior communicating artery (64/182, 35.2%), internal carotid artery ophthalmic artery segment (29/182, 15.9%), and middle cerebral artery bifurcation (27/182, 14.8%). Stents were placed in the anticipated anatomic location in all patients. The study met both primary safety and efficacy end points. The composite primary efficacy end point of complete aneurysm occlusion (Raymond-Roy 1) without parent artery stenosis or aneurysm retreatment was achieved in 84.7% (95% CI, 78.6%–90.9%) of patients. Overall, 4.4% (8/182, 95% CI, 1.9%–8.5%) of patients experienced a primary safety end point of major ipsilateral stroke or neurological death.Conclusions:In the ATLAS IDE anterior circulation aneurysm cohort premarket approval study, the Neuroform Atlas stent with adjunctive coiling met the primary end points and demonstrated high rates of long-term complete aneurysm occlusion at 12 months, with 100% technical success and <5% morbidity.Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT02340585.

中文翻译：

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神经形态学地图集支架的枢纽试验治疗前循环动脉瘤：一年的结果。

背景与目的：使用新一代Neuroform Atlas支架系统的支架辅助线圈栓塞术已显示出有希望的安全性和有效性。Neuroform Atlas支架系统治疗宽颈，囊状，颅内，动脉瘤的前循环动脉瘤队列的初步研究结果（ATLAS试验[Neuroform Atlas治疗宽颈，囊状颅内动脉瘤的安全性和有效性方法：ATLAS IDE试验（研究性设备豁免）是一项前瞻性，多中心，单臂，开放标签的宽颈（颈≥4mm或穹顶颈比<2）的研究。 Neuroform Atlas支架和经批准的线圈治疗前循环颅内动脉瘤。主要疗效终点是在12个月的血管造影上完全动脉瘤闭塞（Raymond-Roy 1级），在目标位置没有再治疗或父母动脉狭窄（> 50％）。主要安全终点是12个月内发生任何重大中风或同侧中风或神经系统死亡。由独立的影像核心实验室和临床事件委员会对主要终点进行判定。结果：美国25个中心共纳入182例宽颈前循环动脉瘤患者。平均年龄为60.3±11.4岁，女性为73.1％（133/182），白人为80.8％（147/182）。平均动脉瘤大小为6.1±2.2 mm，平均颈宽为4.1±1.2 mm，平均穹顶颈比为1.2±0.3。最常见的动脉瘤部位是前交通动脉（64 / 182，35.2％），颈内动脉眼动脉段（29 / 182，15.9％）和大脑中动脉分叉（27 / 182，14.8％）。所有患者均将支架放置在预期的解剖位置。该研究达到了主要的安全性和有效性终点。84.7％（95％CI，78.6％–90.9％）的患者达到了完全动脉瘤闭塞的综合主要疗效终点（Raymond-Roy 1），而没有父母动脉狭窄或动脉瘤再治疗。总体而言，有4.4％（8/182，95％CI，1.9％–8.5％）的患者经历了主要的同侧中风或神经系统死亡的主要安全终点。结论：在ATLAS IDE前循环动脉瘤队列上市前研究中，附有辅助线圈的Neuroform Atlas支架达到了主要终点，并且在12个月时显示出较高的长期完全动脉瘤闭塞率，拥有100％的技术成功率和<5％的发病率。注册网址：https：//www.clinicaltrials.gov。唯一标识符：NCT02340585。