新一代涂层FRED血流导向装置临床前在体结果
在兔弹性蛋白酶诱导的动脉瘤模型中，8只新西兰白兔植入FRED Omega血流导向装置并维持单抗血小板治疗。第28天时7/8（87.50%）动脉瘤达到完全或近完全闭塞，所有支架贴壁良好（8/8，100.00%），无血栓及内膜增生迹象，新生内膜比率平均为0.068。
要点
- FRED Omega在兔动脉瘤模型中28天完全或近完全闭塞率达87.50%（7/8）。
- 所有支架贴壁良好（OCT确认8/8，100.00%），无血栓及血流异常。
- 组织学与ESEM显示全部支架表面新生组织良好（8/8，100.00%）。
关键影像表现/征象
- 第28天血管造影显示87.50%（7/8）动脉瘤达到完全或近完全闭塞。
- OCT确认所有支架贴壁良好（100.00%，8/8），无血栓、血流异常或内膜增生迹象。
- 组织学和ESEM显示每个血流导向装置表面均有组织良好的新生组织（100.00%，8/8），多光子显微镜为75.00%（6/8）。
- 新生内膜比率定量测量结果优异，平均值为0.068。
临床应用与阅片要点
- 该 preclinical 结果提示FRED Omega在单抗血小板治疗下具有较好的动脉瘤闭塞和内皮化潜力。
- 影像随访中可关注支架贴壁情况和动脉瘤闭塞程度，OCT有助于评估贴壁。
- 动物模型结果需谨慎外推至临床，人体疗效和安全性尚待验证。
局限性
- 样本量小（8只兔），属于临床前动物研究，结果不能直接推广至人类。
- 仅评估28天短期结果，缺乏长期随访数据。
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
英文原文（摘要）· 点击展开
BACKGROUND: The introduction of coatings on flow diverter stents (FD) marks a significant evolution in neurovascular intervention for aneurysm embolization. FDs represent a major innovation in the treatment of intracranial aneurysms by promoting endothelial healing and reconstructing the parent artery. FRED Omega is a new generation FD featuring a poly(2-methoxyethyl acrylate) (PMEA)-based surface modification designed to reduce thrombogenicity while maintaining endothelialization. This preclinical study assessed the biocompatibility and aneurysm occlusion efficacy of FRED Omega in a rabbit elastase aneurysm model.
METHODS: Eight New Zealand white rabbits were implanted with FRED Omega across elastase-induced aneurysms and maintained on single antiplatelet therapy (SAPT). Angiography, cone-beam computed tomography, and optical coherence tomography (OCT) were used to evaluate device performance. Histology, environmental scanning electron microscopy (ESEM) and multiphoton microscopy analyses (MM) were conducted on explanted tissues.
RESULTS: At day 28, 7 aneurysms (87.50%, 7/8) achieved complete or near-complete occlusion. All implants remained stable over the time study. All vessels were clear of thrombus with no flow abnormalities nor sign of intimal hyperplasia. OCT confirmed these data associated with good wall apposition for all stents (100.00%, 8/8). Histology and ESEM showed well-organized new tissue on each FD (100.00%, 8/8), compared to 75.00% for MM (6/8, 75.00%). Quantitative measurement of neointimal ratio was excellent with an average of 0.068.
CONCLUSION: FRED Omega demonstrated promising preclinical performance with enhanced endothelialization and aneurysm occlusion in a validated animal model under SAPT.
引用
- Forestier G, Chauvet R, Baudouin M, et al. Preclinical in vivo results of the new generation coated FRED Flow Diverter. AJNR Am J Neuroradiol. 2026. PMID: 42177093. doi:10.3174/ajnr.A9431
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。