Translational Methods for Risk Assessment in Endovascular Treatment of Peripheral Arterial Diseases

This dissertation investigates peripheral arterial disease (PAD), a condition associated with high morbidity and mortality, from three perspectives: fundamental research, imaging, and regulation.

Part I focuses on balloon angioplasty (BA) and the resulting damage to the vascular endothelium. An ex vivo flow model was developed and validated to study this damage in pig arteries. BA was found to cause significant endothelial injury and reduced vascular function. A balloon-to-artery ratio of 1.3:1 resulted in greater damage compared to lower ratios. Two preservation methods were compared: cold static preservation (CS) caused more endothelial loss than warm perfusion (WP), but WP led to reduced vascular responsiveness. The model is therefore suitable for short-term damage assessment, but has limitations in evaluating long-term vascular function.

Part II introduces the length-adjusted calcium score (LACS), a method to quantify arterial calcium load in the lower limbs using contrast-enhanced CT. This score showed good agreement with established methods. When applied to patients with chronic limb-threatening ischemia (CLTI), a high LACS was significantly associated with complications such as amputations and mortality after endovascular treatment. LACS thus provides clinical value for risk stratification.

Part III discusses the impact of new European regulations for medical devices. These stricter rules aim to enhance patient safety through more stringent requirements and increased transparency. At the same time, innovative approaches such as 'safe-by-design' and 'production-by-manufacturability' are proposed to ensure the development of safe and innovative medical devices without hindering innovation.