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In silico trials for drug elung BVS design, development and evaluaon The aim of InSilc is to develop an in silico clinical trial (ISCT) plaorm for designing, developing and assessing drug-elut- ing bioresorbable vascular scaffolds (BVS), by building on the comprehensive biological and biomedical knowledge and advanced modelling approaches, to simulate their implanta- on performance in the individual cardiovascular physiology. In silico Clinical Trials In silico Clinical Trial refers to the use of computer modelling and simulaon for evaluang the safety and efficacy of a medical device, drug or integrated treat- ment approach. Currently the evaluaon of safety and efficacy is performed through in vitro, in vivo tests and clinical trials. InSilc advances the development pipeline of stents through the creaon of five “what if” in silico scenarios for providing predicons of the device performance and interacon with the surrounding environment in the short and medium/long term. +30 265 100 9006 [email protected] www.insilc.eu @InSilc.EU InSilc Coordinator: Prof. Dimitrios I. Fotiadis This project has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under grant agreement No 777119. Consorum This flyer reflects only the author’s view and the Commission is not responsible for any use that may be made of the information it contains.

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Page 1: In silico Clinical Trials

In silico trials for drug eluting BVS design,development and evaluationThe aim of InSilc is to develop an in silico clinical trial (ISCT) platform for designing, developing and assessing drug-elut-ing bioresorbable vascular scaffolds (BVS), by building on the comprehensive biological and biomedical knowledge and advanced modelling approaches, to simulate their implanta-tion performance in the individual cardiovascular physiology.

In silico Clinical TrialsIn silico Clinical Trial refers to the use of computer modelling and simulation for evaluating the safety and efficacy of a medical device, drug or integrated treat-ment approach. Currently the evaluation of safety and efficacy is performed through in vitro, in vivo tests and clinical trials. InSilc advances the development pipeline of stents through the creation of five “what if” in silico scenarios for providing predictions of the device performance and interaction with the surrounding environment in the short and medium/long term.

+30 265 100 9006

[email protected]

www.insilc.eu

@InSilc.EU

InSilc

Coordinator: Prof. Dimitrios I. Fotiadis

This project has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under grant agreement No 777119.

Consortium

This flyer reflects only the author’s view and the Commission is not responsible for any use that may be made of the information it contains.

Page 2: In silico Clinical Trials

MODULESPLATFORM

3D TAWSS

Follow-up

1h

6h

3d 7d

28d1d

Deployment Module

Lumen Gain: 59%

Malapposi�on: No

0 30 60

Max Principal Strain [%]

-10 10 30

Max Principal Stress [MPa]

Provides a new approach to end users by provid-ing them all stent standard tests in silico.

Provides predictions of myocardial perfusion in the cardiac muscle.

The purpose of the model is to make an in silico prediction of the effects of the stenting proce-dure just after the stent deployment.

Predicts the micro/macro phenomena in blood and in stent restenosis after scaffold implanta-tion.

Includes three-dimensional modelling of drug release employing most novel types of anti-pro-liferation drugs.

Predicts the degradation and long-term mechanical performance of the several biore-sorbable material/device systems, through an advanced modelling framework.

Modules Validation: According to ASME V&V40 - Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices

Mechanical Modelling Module

Myocardium Perfusion Module

Deployment Module

Fluid Dynamics Module

Drug-delivery Module

Degradation Module

3D Reconstruction and Plaque Characterization ToolThe 3D Reconstruction and Plaque Characterization Tool is an integrated software tool that can be used to accurately reconstruct a part of the arteri-al tree including the lumen, the outer wall, as well as the plaques. The tool provides also the ability to accurately reconstruct the post-implantation stent configuration.

Virtual PopulationThe “virtual” population database allows the evaluation of BVS efficacy and safety and the prediction of the interaction with the surrounding environ-ment and the scaffold performance through the different virtual scenarios. The virtual database can be found at the website: cardiovascularvirtualpopulation.eu, which is open to researchers.

LogDatabase

EntityDatabase

StentRepository

Virtual CaseRepository

ResultRepository

INSILC CLOUD DATABASE STORAGE

INSILC CLOUDFILE STORAGE

INSILC CLOUD

InSilcRESTAPI

Statistics

Identify Provider

Experiment Setup Managerand Validator

WorkflowManager

WorkflowRegistry

MODULES

Log and Monitoring

Hub

Hub UIApp

AutomatedAgents

File transferManagerData Query/Provider

INSILCHUB NODE

LocalRepository

INSILCWEB APP

Experiment UI

2D Visualization

3D Visualization

AuthenticationManager

3D Reconstruction and Plaque

Characterization Tool

Local HPC Resources