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.