The EU-funded InSilc project has started working on a digital clinical trial platform for assessing coronary artery treatment in a virtual environment.
Coronary artery disease remains the leading cause of mortality worldwide and accounts for over 4 million deaths per year - close to half of all deaths in Europe.
Coronary stents are currently the most widely used for treating symptomatic coronary disease. But the permanent presence of a metallic platform and the durable polymer can impair the natural healing process of the coronary vessel wall, leading to a prolonged inflammatory response.
In recent years, bioresorbable vascular scaffolds (BVS) have emerged as an interesting alternative: this prosthesis in the coronary artery is bioresorbable and therefore impernanent.
The InSilc experts from Belgium, Greece, Italy, Ireland, the Netherlands, Serbia, the United Kingdom and the US have started their work on an in silico (computer modelling) clinical trial platform: 'Virtual' patients will 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.
Better assessment and reduced complications
By integrating the information obtained from different in-silico predictive models, InSilc will:
- Assist in the development, assessment and optimization of the drug-eluting BVS and deliver accurate and reliable information to the Stent Biomedical Industry;
- 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.
Reduced costs and animal testing
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.
EU and transatlantic cooperation
This project was awarded a maximum budget of € 5,839,656.25 under the framework program for research and innovation Horizon 2020, and integrates research groups, universities and companies from Belgium, Greece, Italy, Ireland, Netherlands, Serbia, the United Kingdom and the US.