Objectives Intracranial arteriosclerotic disease is a relevant cause of ischemic stroke worldwide with a high recurrence rate despite best medical treatment. Following the SAMMPRIS trial, endovascular treatment has remained a second-line therapy. Meanwhile, there has been significant advances in device technology. SeQuent Please NEO is a novel polymer-free, drug-coated (paclitaxel/iopromide) balloon (DCB) primarily designed for cardiology. Because of its high flexibility and pushability, it may also be suitable for intracranial use. The aim of this study was to assess the feasibility and safety of SeQuent Please NEO DCB in symptomatic intracranial severe stenosis.
Methods A single-center retrospective cohort study of patients with symptomatic intracranial severe stenosis treated with SeQuent Please NEO DCB was performed at a tertiary stroke center.
Results Ten patients (all men, median age 73 years (IQR 69–77)) were included. Median pre-treatment stenosis grade was 78% (IQR 75–80%) with four internal carotid artery, two mid-basilar artery, and four vertebral artery lesions. Median post-treatment stenosis grade was 50% (IQR 45–53%). Successful angioplasty was achieved in all cases without technical failure. There were no cases of peri-procedural reocclusion and no deaths at median follow-up of 3 months (IQR 2–3).
Conclusion In this pilot study, SeQuent Please NEO DCB was feasible and safe in the treatment of symptomatic intracranial severe stenosis. It might represent a promising alternative to medical treatment in selected cases.
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Contributors PG: substantial contributions to the conception and design of the work; acquisition, analysis, and interpretation of data, and writing the manuscript. CB: acquisition of data and revising it critically for important intellectual content. JB, TK, JA: substantial contributions to the conception and design of the work and revising it critically for important intellectual content. MH, MD, KN: revising the work critically for important intellectual content. LR: conception and design of the work, revising it critically for important intellectual content, and final approval of the version to be published.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent Not required.
Ethics approval EKNZ.
Provenance and peer review Not commissioned; externally peer reviewed.