ArticleJournal of neuroimaging : official journal of the American Society of Neuroimaging
Preclinical Evaluation of a Zotarolimus-Eluting Stent for Intracranial Application: A 30-Day Procedural Feasibility and Clinical Observation Canine Study.
Article in Journal of neuroimaging : official journal of the American Society of Neuroimaging. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
background and purposeZotarolimus-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.
methodsIn 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.
resultsTechnical 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.
conclusionImplantation 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.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.