法国分流治疗IA：对注册影响的初步结果

IF 3 3区医学 Q2 CLINICAL NEUROLOGY

Journal of Neuroradiology Pub Date : 2025-02-19 DOI:10.1016/j.neurad.2025.101272

Jonathan Larochelle , Jean-Christophe Gentric , Erwah Kalsoum , Alias Quentin , Xavier Barreau , Richard Bibi , Tamar Roomian , Zsolt Kulcsar

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引用次数: 0

摘要

前言颅内动脉瘤血管内分流支架治疗在临床中应用广泛。我们揭示了IMPACT EVOLVE FR Registry的主要性能和安全性结果，这是首个在法国多中心队列中使用transcend EVOLVE治疗IA的研究。simpact EVOLVE FR是一项前瞻性、非介入性、多中心注册研究，旨在通过术后12个月（±6个月）评估法国人群中接受transcend EVOLVE治疗的IA患者的安全性。中心核心实验室判定的主要表现指标是12个月时的综合参数，包括：(1)目标动脉瘤100%闭塞，按雷蒙德（RR）量表1级衡量；(2)无目标动脉狭窄(>；50%)和(3)无目标动脉瘤再治疗。次要性能指标包括术后12个月的靶闭塞状态（RR1/RR2/RR3）和12个月时与基线相比的动脉瘤大小。次要安全终点包括手术和器械相关的严重不良事件（sae），手术后12个月的任何关键神经系统事件，包括：神经死亡定义为卒中相关死亡，靶动脉瘤破裂/再破裂，卒中（主要/轻微，缺血性/出血性，同侧/对侧），或颅内出血（实质/蛛网膜下腔），以及短暂性脑缺血发作。在2021年8月至2023年3月期间，17个站点的203名患者符合条件并入组IMPACT FR。将描述性地呈现主要性能结果，并给出置信区间。二级性能指标也将被描述。IMPACT EVOLVE FR注册表代表了真实世界的数据，旨在为法国治疗IA的transcend EVOLVE Flow Diverter提供上市后安全性和性能评估。此外，对IMPACT注册表的各个子队列的后续分析可能有助于确定未来的研究问题。

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Flow diversion for the treatment of IA in France : preliminary results of the impact fr registry

Introduction

Intracranial Aneurysm endovascular treatment using flow diverter stents is widely used in clinical practice. We reveal the primary performance and safety outcomes findings of the IMPACT EVOLVE FR Registry, which is the first study of the use of Surpass Evolve in a multicenter French cohort for the treatment of IA.

Methods

IMPACT EVOLVE FR is a prospective, non-interventional, multicenter registry to assess the safety of patients presenting an IA treated with Surpass Evolve in a French population, through 12 months post-procedure (± 6 months). The central core lab adjudicated primary performance measure was a composite parameter at 12 months comprising of: (1) 100% occlusion of the target aneurysm, as measured by a grade 1 on the Raymond (RR) scale, (2) no target artery stenosis (> 50%), and (3) no target aneurysm retreatment. The secondary performance measures included target occlusion status (RR1/RR2/RR3) through 12 months post-procedure, and aneurysm size at 12 months compared to baseline. Secondary safety endpoints included procedural and device-related serious adverse events (SAEs) through 12 months post-procedure, any key neurological event of interest through 12 months post-procedure, including: neurological death defined as stroke-related death, target aneurysm rupture/re-rupture, stroke (major/minor, ischemic/hemorrhagic, ipsilateral/contralateral), or intracranial hemorrhage (parenchymal/subarachnoid), and transient ischemic attack.

Results

Between August 2021 and March 2023, 203 patients were eligible and enrolled in IMPACT FR across 17 sites. The primary performance outcome will be presented descriptively, along with a confidence interval. Secondary performance measures will also be described.

Conclusions

The IMPACT EVOLVE FR Registry represents real-world data designed to provide post-market safety and performance evaluation of Surpass Evolve Flow Diverter in France for the treatment of IA. Additionally, subsequent analyses of various sub cohorts of the IMPACT Registry may aid to identify future research questions.

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来源期刊

Journal of Neuroradiology 医学-核医学

CiteScore

6.10

自引率

5.70%

发文量

142

审稿时长

6-12 weeks

期刊介绍： The Journal of Neuroradiology is a peer-reviewed journal, publishing worldwide clinical and basic research in the field of diagnostic and Interventional neuroradiology, translational and molecular neuroimaging, and artificial intelligence in neuroradiology. The Journal of Neuroradiology considers for publication articles, reviews, technical notes and letters to the editors (correspondence section), provided that the methodology and scientific content are of high quality, and that the results will have substantial clinical impact and/or physiological importance.