Preclinical Evaluation of a Zotarolimus-Eluting Stent for Intracranial Application: A 30-Day Procedural Feasibility and Clinical Observation Canine Study.
IA, B., F, J., H, T., H, B., SA, G., R, N., I, K., A, R., B, J., & AE, H. (2026). Preclinical Evaluation of a Zotarolimus-Eluting Stent for Intracranial Application: A 30-Day Procedural Feasibility and Clinical Observation Canine Study.. Journal of neuroimaging : official journal of the American Society of Neuroimaging. https://doi.org/10.1111/jon.70141
IA B, F J, H T, H B, SA G, R N, et al. Preclinical Evaluation of a Zotarolimus-Eluting Stent for Intracranial Application: A 30-Day Procedural Feasibility and Clinical Observation Canine Study.. Journal of neuroimaging : official journal of the American Society of Neuroimaging. 2026; doi: 10.1111/jon.70141
IA B, F J, H T, et al. Preclinical Evaluation of a Zotarolimus-Eluting Stent for Intracranial Application: A 30-Day Procedural Feasibility and Clinical Observation Canine Study.[J]. Journal of neuroimaging : official journal of the American Society of Neuroimaging. 2026. DOI: 10.1111/jon.70141.
@article{ia2026,
author = {Bhatti IA and Jumah F and Tolba H and Brooks H and Gillani SA and Nunna R and Khan I and Rolfes A and Jagadeesan B and Hassan AE},
title = {Preclinical Evaluation of a Zotarolimus-Eluting Stent for Intracranial Application: A 30-Day Procedural Feasibility and Clinical Observation Canine Study.},
journal = {Journal of neuroimaging : official journal of the American Society of Neuroimaging},
year = {2026},
doi = {10.1111/jon.70141},
note = {PMID: 42578539},
}
TY - JOUR AU - Bhatti IA AU - Jumah F AU - Tolba H AU - Brooks H AU - Gillani SA AU - Nunna R AU - Khan I AU - Rolfes A AU - Jagadeesan B AU - Hassan AE TI - Preclinical Evaluation of a Zotarolimus-Eluting Stent for Intracranial Application: A 30-Day Procedural Feasibility and Clinical Observation Canine Study. T2 - Journal of neuroimaging : official journal of the American Society of Neuroimaging PY - 2026 DO - 10.1111/jon.70141 AN - PMID:42578539 ER -
BACKGROUND AND PURPOSE: Zotarolimus-eluting stents (ZES) are increasingly used off-label for intracranial atherosclerotic disease (ICAD), yet foundational preclinical data evaluating procedural delivery and short-term vascular safety in cerebral anatomy is sparse. We evaluated the procedural feasibility and 30-day clinical safety of the Onyx Frontier ZES in a canine intracranial model. METHODS: In a prospective study, 12 healthy canines on dual antiplatelet therapy underwent basilar artery implantation of a 2.0 × 8.0 mm Onyx Frontier ZES. Vertebral artery tortuosity was angiographically graded as Type I (mild), II (moderate), or III (severe). Endpoints focused on procedural success and 30-day clinical safety, monitored via angiography, serial neurological examinations, and clinical pathology. RESULTS: Technical success was 100% (12/12) despite challenging anatomy (mean basilar artery diameter: 1.39 mm). Tortuosity distribution was 33.3% Type I, 58.3% Type II, and 8.3% Type III. Post-deployment angiographic narrowing consistent with transient vasospasm was observed in 7/12 animals, without flow limitation; with only one requiring intra-arterial verapamil for resolution. One instance (8.3%) of self-limiting contrast extravasation occurred at the distal basilar artery without long-term sequelae. At 30 days, there was 0% mortality and no procedure-related neurological adverse events. Serial clinical pathology panels demonstrated an absence of systemic organ toxicity or sustained systemic inflammation. CONCLUSION: Implantation of the Onyx Frontier ZES is highly feasible in sub-2 mm, tortuous intracranial vessels. The platform demonstrated an excellent 30-day clinical safety profile, providing essential procedural and early clinical data to support future integrated regulatory evaluations for ICAD.