Background Flow diverters (FDs) are effective in the treatment of carotid aneurysms. Compared with carotid aneurysms, the treatment of distal intracranial aneurysms with FDs has been associated with a relatively high incidence of complications. Low thrombogenic modified-surface FDs may reduce ischemic complications and allow for the use of a single antiplatelet medication. The aim of this study was to assess the safety and efficacy of the p48 MW HPC Flow Modulation Device (Phenox GmbH, Bochum, Germany) to treat distal intracranial aneurysms used in combination with prasugrel monotherapy.
Methods This was a single-center, prospective, pivotal, open, single-arm study. Patients were included in this study from December 2019 to September 2020. The primary endpoints were the incidence of any neurologic deficit after treatment until 1 month of follow-up, defined as National Institutes of Health Stroke Scale (NIHSS) ≥1, and the incidence of acute ischemic lesions in magnetic resonance imagin (MRI) images 48 hours after treatment. The secondary endpoint was the rate of complete occlusion of the aneurysms at the 1-month follow-up.
Results Twenty-one patients harboring 27 distal aneurysms of the anterior circulation were included. Mean age was 57.8 (SD 9.7) years, and 16 patients were female (80%). No patient had neurologic symptoms at the 1-month follow-up. Four patients (20%) had asymptomatic acute brain ischemic lesions on MRI. Complete aneurysm occlusion occurred in 9/27 (33.3%) aneurysms at the 1-month follow-up.
Conclusion In this pilot safety trial, treatment of distal intracranial aneurysms with p48 MW HPC under monotherapy with prasugrel appeared to be safe.
- flow diverter
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Contributors LHdC-A participated in study conception, and drafting and approval of the manuscript. GSN, TGA, LMM, RKF, RSdO, BOC, and ACdS participated in data acquisition, figure/table editing, revision of the manuscript, and final approval. DGA participated in study conception, data acquisition, critical revision of the manuscript, and approval of the final work.
Funding Regarding funding sources, the entire study was conducted in the context of clinical care practice of our Institution. The manufacturer phenox BmbH (Bochum-Germany) supported the study providing all devices p48 MW HPC, prasugrel and VerifyNow tests used in this study. However, the phenox BmbH did not participated in any data collection, management, analysis, interpretation or report results. The phenox did not have any authority regarding decision to publish the results obtained by the coordination center. The coordination center was the sole responsible for all data collection, register, analysis, interpretation and publication of the manuscript.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Unpublished or unprocessed data, protocols and images are available upon request from the corresponding author.
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