Abstract Background and aims Intracranial atherosclerotic disease–related large vessel occlusion (ICAD-LVO) causes a substantial proportion of ischemic strokes and frequently requires rescue stenting after failed thrombectomy, yet zotarolimus-eluting stents such as Onyx Frontier are only approved for coronary use and lack intracranial safety and pharmacokinetic data. This study aims to evaluate the procedural safety, vascular healing, and zotarolimus pharmacokinetics of Onyx Frontier stents deployed in the canine basilar artery as a preclinical model to inform future first-in-human ICAD-LVO rescue stenting trials. Methods In this prospective pilot study, four adult purpose-bred canines will undergo survival surgery with Onyx Frontier zotarolimus-eluting stent deployment in the basilar artery under fluoroscopic guidance by board-certified neurointerventionalists. Primary endpoints are technical success (complete stent expansion and preserved perforator patency on digital subtraction angiography) and safety (absence of vessel perforation, hemorrhage, or peri-procedural neurological deterioration). At 90 days, animals will undergo euthanasia, necropsy, quantitative histopathology to assess endothelialization, neointimal response, and neurotoxicity, and LC-MS–based zotarolimus pharmacokinetic profiling in stented segments, brain regions, and liver. Results Animal study infrastructure and multidisciplinary collaborations with veterinary medicine, neuropathology, and pharmacology have been preliminarily established, and device procurement and protocol finalisation will commence pending confirmation of a funding source for our study. Stent implantation procedures would thereafter commence within the study year, with 90-day survival, necropsy, and tissue analyses expected to yield first-in-kind intracranial zotarolimus safety and pharmacokinetic data that could guide GLP-compliant preclinical studies. Conflict of interest Archit Baskaran: nothing to disclose Julia Iourinets: nothing to disclose Shyam Patel: nothing to disclose Alireza Borghei: nothing to disclose Khalid Trad: nothing to disclose Taraf Jaro: nothing to disclose Tareq Kass-Hout: nothing to disclose
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Archit Baskaran
University of Chicago
Julia Iourinets
University of Chicago
SC Patel
University of Chicago
European Stroke Journal
University of Chicago
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Baskaran et al. (Fri,) studied this question.
synapsesocial.com/papers/69fd7fcdbfa21ec5bbf086b7 — DOI: https://doi.org/10.1093/esj/aakag023.1260