Project title:

In-silico trials for drug-eluting BVS design, development and evaluation

Project acronym: 




The aim of InSilc is to develop an in-silico clinical trial (ISCT) platform for designing, developing and assesing drug-eluting bioresorbable vascular scaffolds (BVS), by building on the comprehensive biological and biomedical knowledge and advanced modelling approaches to simulate their implantation performance in the individual cardiovascular physiology. The InSilc platform is based on the extension of existing multidisciplinary and multiscale models for simulating the drug-eluting BVS mechanical behaviour, the deployment and degradation, the fluid dynamics in the micro- and macroscale, and the myocardial perfusion, for predicting its interaction with the vascular wall in the short- and medium/long term. InSilc goes beyond the design and development of ISCT and lays on the generation of in-silico models for obtaining quick and informed answers to several “What if” scenarios. “Virtual” patients would be given a “virtual” drug-eluting BVS, for observing the performance of the scaffold, assess and quantify the intended effect, with a deeper understanding than normal trials can provide. By integrating the information obtained from different in-silico predictive models, InSilc will: (i) assist in the development, assessment and optimization of the drug-eluting BVS and deliver accurate and reliable information to the Stent Biomedical Industry, (ii) assist the interventional Cardiologists in improving the surgical process of drug-eluting BVS implantation, support them in the clinical assessment and reduce the complications of suboptimal scaffold performance. By introducing computer simulations for establishing the safety and efficacy of drug-eluting BVS, InSilc aims to lower development costs and shorten time-to-market, reduce, refine, and partially replace human clinical trials through a more effective human clinical trials design, reduce the need for animal testing and result in a significant reduction of the associated direct and indirect costs.


01.11.2017 – 31.10.2020

Funded by:

Horizon 2020 programme, the European Commission


Foundation for Research and Technology Hellas, Greece


InSilc objectives:

OBJ1: To collect retrospective and prospective data at different time points (baseline and follow up) for creating the InSilc “virtual” population.

OBJ2: To perform in vitro experiments for defining the mechanical properties and evaluating the performance of the drug-eluting BVS.

OBJ3: To perform in vitro experiments for evaluating the protein expression and pathways related to cell-based models of ISR to be utilised by the Fluid Dynamics and the Drug-Delivery Modules.

OBJ4: To refine and validate the existing multidisciplinary and multiscale models, towards simulating the short and medium/long terms effects of drug-eluting BVS implantation.

OBJ5: To integrate the multidisciplinary and multiscale models into the Cloud-based InSilc platform.

OBJ6: To conduct a prospective animal study and a proof of concept clinical study for refining and validating the InSilc platform.

OBJ7: To support the Stent Biomedical Industry in carrying out clinical trials for new drug-eluting BVS in-silico through the creation of “virtual” scenarios of drug-eluting BVS implantation.

OBJ8: To provide a preliminary framework for the adoption of in-silico clinical trials for drug-eluting BVS through the analysis of the regulations, ethical issues, standards and processes towards the design of more effective human clinical trials.

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