Scenarios

Several scenarios were identified to demonstrate the applicabilty of the InSilc Platform. The development of these scenarios is a result of a direct interaction with industrial and medical device partners, as well as engagement with key clinical and regulatory stakeholders that provide perspectives issues such as surgical procedures and clinical trial design considerations. These scenarios aim to provide an understanding into product design, development and optimisation pathways, These scenarios will be employed to develop the InSilc platform in the most efficient way and optimise the platform for use of different end users in different product development and use scenarios. They will also serve for assessment of project progress and review. Scenario 1 – Compare existing stents For the selected virtual anatomy: (i) the stenting outcomes in terms of deployment, drug release, hemodynamics, degradation, wall response and major adverse cardiac events are predicted for two stents (BRS and partially degradable stent, already available in the Virtual stent database) and suitably compared. Scenario 2 – Compare anatomy configurations and patient conditions For a stent, the procedure outcome in terms of deployment, drug release, hemodynamics, wall response and major adverse cardiac events are predicted considering different virtual anatomies (at least one of them, in principle, is not indicated for the treatment with the considered stent). Scenario 3 – Compare different clinical procedures For the selected virtual anatomy and the considered stent, the stenting outcome in terms of deployment, drug release, hemodynamics, wall response and major adverse cardiac events are predicted, when different implantation procedures are simulated. Scenario 4 – Design entirely new stents For the selected virtual anatomy the stenting outcomes in terms of deployment, drug release, hemodynamics, degradation, wall response and major adverse cardiac events are predicted, when parameters such as design or material are changed in a specific stent. Scenario 5 – Pre-clinical testing assessment All the stent manufacturers have to perform standard mechanical stent testing according to ISO. Aim of achieving a stent design that successfully passes all the necessary tests, the process is slow and expensive, requiring many cycles of mechanical testing and redesigning of the initial stent model. In silico mechanical test will assist in reducing the required number of real mechanical test and the associated costs. Virtual Scenarios This capability allows users to compare the performance of different stents and/or stent designs implanted in the same artery or compare outcomes of clinical different procedures to treat the same stenotic artery. In the figure below, Scenario 2 is shown, whereby the same stent has been used to treat two different virtual patient anatomies and direct side-by-side comparisons of performance outcomes in Deployment, Fluid dynamic and Drug delivery modules are shown.
By integrating the information obtained from these different in silico predictive models, the InSilc Cloud Platform enables the development, assessment and optimization of coronary stents and delivers accurate and reliable information to the Stent Biomedical Industry. The next phase for the InSilc Cloud Platform will focus on the exploitation of results and commercialisation of this innovative technology, which has the potential to streamline the design and development of new coronary stents.