INSILC: In-silico trials for drug-eluting bioresorbable vascular scaffold design, development and evaluation
- Start date: 1 November 2017
- End date: 31 October 2020
- Funder: EU Horizon 2020
- Value: €5,839,656
- Partners and collaborators: Foundation for Research and Technology Hellas, Greece (coordinators) University of Leeds Erasmus Medical Center, The Netherlands Politecnico di Milano, Italy CNR Institute of Clinical Physiology, Italy Mediolanum Cardio Research Srl, Italy FEOPS NV, Belgium NUI Galway, Ireland BIOIRC, Serbia University of Ioannina, Greece CBSET, USA Boston Scientific Ltd, Ireland
- Primary investigator: Professor Alejandro F Frangi
- Co-investigators: Dr Ali Sarrami-Foroushani, Dr Nishant Ravikumar
The advent of drug-eluting bioresorbable vascular scaffolds (BVS) have emerged as a potential major breakthrough for treatment of coronary artery lesions. In principle, the need for vessel scaffolding and drug delivery is temporary, rendering a permanent stent superfluous once the vessel has healed and the processes of recoil and hyperplasia have ended. Conventional permanent stent implantation precludes future surgical revascularization, complicates recrossing into side branches, eliminates reactive vasomotion, impairs noninvasive imaging, and exposes patients to the risk of very late thrombosis. These long-term limitations of conventional stents may be overcome to a degree by using drug-eluting BVS.
However, today, the only conclusive (and accepted) way to ensure the safety and efficacy of a drug-eluting BVS is to test it in the laboratory (in vitro), and then on living organisms, initially on animals (in vivo) and then on humans (clinical evaluation/trial). During the last decade, there has been a huge investment in information technology and in-silico modelling for the development of biomedical products. In-silico technologies are of great value, and could answer several difficult questions, such as: “Why do some patients react adversely to the implantation of a drug-eluting BVS, while others not?”
InSilc will provide the ability to evaluate how drug-eluting BVS affect individual patients and address this individual variability. InSilc develops a simulation platform for setting up and administering virtual in-silico trials for new BVS stents. It pools together Europe-wide know-how about biomechanics, fluid dynamics and coronary stent modelling to develop a fully-validated modelling platform.
The platform is aimed at investigating specific scenarios that compare BVS stents in typical R&D and clinical trial scenarios and aims to produce evidence that can be used by a medical device manufacturer to develop these challenging devices quicker, more safely, and more cost-effectively. All this is done in collaboration with cardiologists running a prospective study in parallel to collect patient-specific data and follow-up a cohort of coronary stenting patients to validate the predictions of the virtual BVS models.
InSilc demonstrates the viability of virtual in-silico trials in the development of novel medical devices. It develops concrete tools for setting up and administering virtual in-silico trials for coronary stents. Individual modules developed within InSilc (e.g. for stent mechanical durability testing, stent deployment, coronary vascular flow modelling, stent degradation or drug elution) will be made available for licensing by companies interested in using them for accelerating their R&D pathway by simulation and virtual in-silico trials.