In-silico clinical trials for cost-effective assessment and development of safe and clinically effective medical devices: aortic stent graft

TRIALIX will develop in-silico trials solutions for product design, development and assessment of stent grafts for endovascular aneurysm repair or endovascular aortic repair (EVAR). Stent grafts are the most commonly devices used for abdominal aortic aneurism repair increasing from 32% in 2001 to 65% in 2006 [1]. The TRIALIX in-silico tools will enable the safety and efficacy of existing stent grafts to be assessed and compared against clinical trial results to validate their results and optimise the developed algorithms and process pipelines. By building on extensive existing data available to the consortium and leveraging its comprehensive biomedical, technological, market and surgical knowledge we will simulate both the device characteristics and features and the human physiology and pathophysiology to create virtual patient cohorts in which to then simulate novel stent graft designs and material components to explore and predict failure modes in-silico. Moreover, the computational models and patient database will enable the in-silico matching of stent graft to patients and the prediction of outcomes, thus advancing the prospects of using the most appropriate or even personalised devices for individual patients.