The use of experimental preclinical models in evaluating endovascular interventions for vascular access stenosis: A review.

Abstract

Stenosis of vascular accesses, particularly in arteriovenous fistulas and grafts, remains a significant challenge in hemodialysis patients, often leading to access dysfunction and failure. Endovascular interventions, including stent grafts and drug-coated balloons (DCBs), have emerged as key treatment modalities to mitigate restenosis and prolong access patency beyond simple balloon angioplasty. Preclinical evaluation of these devices relies on large animal models to assess safety, effectiveness, and biological responses before clinical application. This review provides a comprehensive analysis of the large animal models used for evaluating endovascular devices in vascular access stenosis, highlighting their advantages, limitations, and translational relevance. Additionally, we summarize premarket approval (PMA) animal studies for seven endovascular devices currently indicated for use in vascular accesses, examining their study designs, key findings, and regulatory considerations. By synthesizing preclinical data, this review aims to inform future research and regulatory strategies for optimizing endovascular therapies in vascular access management.