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How to Validate in silico Deployment of Coronary Stents: Strategies and Limitations in the Choice of Comparator

This study aims at proposing and discussing useful indications to all those who need to validate a numerical model of coronary stent deployment. The proof of the reliability of a numerical model is becoming of paramount importance in the era of in silico trials. Recently, the ASME V&V Standard C...

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Autores principales: Berti, Francesca, Antonini, Luca, Poletti, Gianluca, Fiuza, Constantino, Vaughan, Ted J., Migliavacca, Francesco, Petrini, Lorenza, Pennati, Giancarlo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8757815/
https://www.ncbi.nlm.nih.gov/pubmed/35047942
http://dx.doi.org/10.3389/fmedt.2021.702656
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author Berti, Francesca
Antonini, Luca
Poletti, Gianluca
Fiuza, Constantino
Vaughan, Ted J.
Migliavacca, Francesco
Petrini, Lorenza
Pennati, Giancarlo
author_facet Berti, Francesca
Antonini, Luca
Poletti, Gianluca
Fiuza, Constantino
Vaughan, Ted J.
Migliavacca, Francesco
Petrini, Lorenza
Pennati, Giancarlo
author_sort Berti, Francesca
collection PubMed
description This study aims at proposing and discussing useful indications to all those who need to validate a numerical model of coronary stent deployment. The proof of the reliability of a numerical model is becoming of paramount importance in the era of in silico trials. Recently, the ASME V&V Standard Committee for medical devices prepared the V&V 40 standard document that provides a framework that guides users in establishing and assessing the relevance and adequacy of verification and validation activities performed for proving the credibility of models. To the knowledge of the authors, only a few examples of the application of the V&V 40 framework to medical devices are available in the literature, but none about stents. Specifically, in this study, the authors wish to emphasize the choice of a relevant set of experimental activities to provide data for the validation of computational models aiming to predict coronary stent deployment. Attention is focused on the use of ad hoc 3D-printed mock vessels in the validation plan, which could allow evaluating aspects of clinical relevance in a representative but controlled environment.
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spelling pubmed-87578152022-01-18 How to Validate in silico Deployment of Coronary Stents: Strategies and Limitations in the Choice of Comparator Berti, Francesca Antonini, Luca Poletti, Gianluca Fiuza, Constantino Vaughan, Ted J. Migliavacca, Francesco Petrini, Lorenza Pennati, Giancarlo Front Med Technol Medical Technology This study aims at proposing and discussing useful indications to all those who need to validate a numerical model of coronary stent deployment. The proof of the reliability of a numerical model is becoming of paramount importance in the era of in silico trials. Recently, the ASME V&V Standard Committee for medical devices prepared the V&V 40 standard document that provides a framework that guides users in establishing and assessing the relevance and adequacy of verification and validation activities performed for proving the credibility of models. To the knowledge of the authors, only a few examples of the application of the V&V 40 framework to medical devices are available in the literature, but none about stents. Specifically, in this study, the authors wish to emphasize the choice of a relevant set of experimental activities to provide data for the validation of computational models aiming to predict coronary stent deployment. Attention is focused on the use of ad hoc 3D-printed mock vessels in the validation plan, which could allow evaluating aspects of clinical relevance in a representative but controlled environment. Frontiers Media S.A. 2021-08-17 /pmc/articles/PMC8757815/ /pubmed/35047942 http://dx.doi.org/10.3389/fmedt.2021.702656 Text en Copyright © 2021 Berti, Antonini, Poletti, Fiuza, Vaughan, Migliavacca, Petrini and Pennati. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Medical Technology
Berti, Francesca
Antonini, Luca
Poletti, Gianluca
Fiuza, Constantino
Vaughan, Ted J.
Migliavacca, Francesco
Petrini, Lorenza
Pennati, Giancarlo
How to Validate in silico Deployment of Coronary Stents: Strategies and Limitations in the Choice of Comparator
title How to Validate in silico Deployment of Coronary Stents: Strategies and Limitations in the Choice of Comparator
title_full How to Validate in silico Deployment of Coronary Stents: Strategies and Limitations in the Choice of Comparator
title_fullStr How to Validate in silico Deployment of Coronary Stents: Strategies and Limitations in the Choice of Comparator
title_full_unstemmed How to Validate in silico Deployment of Coronary Stents: Strategies and Limitations in the Choice of Comparator
title_short How to Validate in silico Deployment of Coronary Stents: Strategies and Limitations in the Choice of Comparator
title_sort how to validate in silico deployment of coronary stents: strategies and limitations in the choice of comparator
topic Medical Technology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8757815/
https://www.ncbi.nlm.nih.gov/pubmed/35047942
http://dx.doi.org/10.3389/fmedt.2021.702656
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