Balloons and Stents and Scaffolds: Preclinical Evaluation of Interventional Devices for Occlusive Arterial Disease

Abstract

Atherosclerosis places a significant burden on humankind; it is the leading cause of mortality globally, and for those living with atherosclerosis, it can significantly impact quality of life. Fortunately, treatment advances have effectively reduced the morbidity and mortality related to atherosclerosis, with one such modality being percutaneous intervention (PCI) to open occluded arteries. Over the 40-year history of PCI, preclinical models have played a critical role in demonstrating proof of concept, characterizing the in vivo behavior (pharmacokinetics, degradation) and providing a reasonable assurance of biologic safety of interventional devices before entering into clinical trials. Further, preclinical models may provide insight into the potential efficacy of these devices with the appropriate study design and end points. While several species have been used in the evaluation of interventional devices, the porcine model has been the principal model used in the evaluation of safety of devices for both coronary and endovascular treatments. This article reviews the fundamentals of permanent stents, transient scaffolds, and drug-coated balloons and the models, objectives, and methods used in their preclinical evaluation.

Injury and Healing Response of Healthy Peripheral Arterial Tissue to Intravascular Lithotripsy: A Prospective Animal Study

“…The neointima scores in the IVL group continually increased from 0 to 28 days. This differed from the POBA group, which demonstrated an initial increase and a subsequent decrease ( 8 ). In this study, the fibrin score was low in both groups, and fibrin was only observed at 5 days postoperatively, but the score in the IVL group was higher than that in the POBA group.…”

Long-acting implantable devices for the prevention and personalised treatment of infectious, inflammatory and chronic diseases

“…Bare metal stents (BMSs) were introduced right after angioplasty balloons (BAs) in order to prevent vessel's elastic recoil [68], a phenomenon characterised by the loss of the luminal areas following overstretch of the vessel wall [69]. They can be balloonexpandable or self-expandable [65].…”

“…Following on the still open challenges, drug eluting stents (DESs) were introduced, finally reducing the frequency of these events [68].…”

Adventitial histopathological changes after coronary stenting in a porcine model

“…More preclinical investigations are necessary to clarify the doubts arising around these devices (Perkins and Rippy 2019). To perform this type of study, coronary arteries from swine are the model of choice because of their similarity to human anatomy and their suitability for analysing the restenosis induced after coronary stenting (Perez de Prado et al 2013).…”

“…To perform this type of study, coronary arteries from swine are the model of choice because of their similarity to human anatomy and their suitability for analysing the restenosis induced after coronary stenting (Perez de Prado et al 2013). The analysis of each vascular layer in the repair process after stent placement is important for the appropriate interpretation of a device's performance (Perkins and Rippy 2019). The first studies attributed a key role in the healing process to the tunica intima (Schwartz et al 1995).…”