The extension to BVS of the “virtual” stenting with patient-specific models of single stenosed or bifurcated coronary arteries will be performed in InSilc. Namely, we will use advanced modelling, with device-specific material properties for BVS and patient-specific models for the stenosed coronary artery. A “virtual” investigation of bifurcation stenting with BVS is an important task since animal and clinical studies indicate that a number of issues occur during BVS deployment, such as strut fracture and malapposition. The results of the InSilc Deployment module directly will provide indications on the short-term BVS behaviour. Moreover, the incorporation of the Deployment Module in the framework of InSilc platform and the coupling with other in-silico modules, Fluid Dynamics module and Degradation module, will provide valuable information regarding the drug-eluting BVS performance and efficacy in medium/long term.
The methodologies adopted for the drug-eluting BVS implantation modelling (scaffold and balloon) are those as described in the previous section – InSilc Mechanical modelling module.
The numerical strategies applied to simulate the complex procedures for bifurcation stenting will refer to previous works of POLIMI.
For the human arterial coronary model that interacts with the drug-eluting BVS we will use: (i) patient – specific data: anatomy (also bifurcations) and plaque composition, acquired as described in the proof of concept clinical study (ii) accurate constitutive models from literature – for the coronary wall we will consider three layers and fiber-reinforcement, for the different types of plaque components, we will use different models for plaque constituents.
A thorough validation of the predictive power of the BVS “virtual” deployment will be performed in InSilc. This is mandatory to guarantee that the results of this in-silico module are reliable inputs for the subsequent modules and allow the use of the InSilc Cloud platform for in-silico clinical trials and preoperative planning of drug-eluting BVS.Since a high number of critical aspects are involved in the simulation of drug-eluting BVS deployment in complex patient-specific coronary arteries, a systematic approach will be used for the validation, comparing numerical results with experimental data deriving from: (i) in vitro BVS deployment in rigid mock vessels, (ii) in vitro BVS deployment in deformable mock vessels, (iii) in vitro BVS deployment in deformable realistic stenotic mock vessels, including different material properties for plaque, (iv) animal studies, (v) proof of concept clinical study.