LAUSR

Background Iliofemoral vein stenosis or occlusion is a common cause of severe chronic venous insufficiency. Endovascular venous stenting has become a preferred treatment because it is minimally invasive and has a high safety profile. Despite the wide application of the wallstent, it is not specifically designed for veins. There are currently few studies on braided stents in the field of veins. We designed a novel braided vein stent, which has higher radial resistive force and more optimized looped ends structure compared with the wallstent. The purpose of this study was to evaluate the safety and performance of the stent in animals, providing a reference for further clinical trials. Methods The Wallstent is used as a control group. The novel stent and the Wallstent were implanted in the iliac vein of sheep. After 30 days and 90 days, vascular injury, thrombus, neointima coverage, and luminal stenosis were evaluated through venous angiography, endoscopic observation of stent specimen and histopathology. Imaging, histology, and integration data were analyzed by t-test for comparisons between the groups. Results Two groups of stents were successfully implanted. Follow-up observation showed that there was no thrombosis or obstruction >50% occurred in any group and no significant differences in patency, vascular injury, or intimal hyperplasia compared with the Wallstent. Conclusion The novel stent significantly increases the radial resistive force and does not increase vascular injury, thrombus and stent stenosis during 30-day and 90-day follow-up. The next step is to further validate the effectiveness of the stent through long-term animal observation and human clinical trials.