Evaluation of a new Everolimus-coated balloon catheter in an in-vivo porcine peripheral venous model.

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Tác giả: Nikolaos Giannikas, Kechagias Ioannis, Dimitrios Karnabatidis, Michail Karpetas, Panagiotis Kitrou, Amalia I Moula, Anargyros N Moulas, Ioannis Paraskevopoulos, Lazaros Reppas, Stavros Spiliopoulos, Michail Theofanis

Ngôn ngữ: eng

Ký hiệu phân loại:

Thông tin xuất bản: Switzerland : CVIR endovascular , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 732951

BACKGROUND: The venous uptake following the application of Everolimus-coated balloons is under reported. We evaluated the feasibility, safety, and Everolimus (EVR) deliverability of a novel non-commercially available Everolimus-Coated Balloon (ECB) catheter in a swine healthy peripheral vein model. METHODS: In total 12 ECBs (5.0 μg/mm RESULTS: Everolimus was detected in 10 out of 12 (83.33%) tissue samples (all six tissue samples at 24 h post-intervention and in four out of six samples at 7 days). The mean weight of the examined tissue was 0.20604 ± 0.29822 g (range: 0.37475-0.02229 g). The average EVR tissue content detected at 24 h (135.67 ± 204.95 μg/g) was numerically superior, but non-statistically significant to the that detected 7 days post-procedure (96.85 ± 110.89 μg/g). The average quantity of EVR on the balloon after retrieval was 33.9% of the initial drug dose. No adverse events were recorded, and no abnormalities were noted during autopsy. CONCLUSIONS: The newly developed ECB successfully delivered Everolimus within the healthy venous wall. No adverse events were noted at a short-term follow-up. RELEVANCE STATEMENT: These safety and feasibility results justify further experimental and clinical research to demonstrate the safety efficacy the specific balloon catheter.
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