The Experimental Study Of Fluoride Coated Sirolimus-eluting Stent In A Porcine Peripheral Artery Model

With the advent of an aging society,the incidence of peripheral artery disease(PAD)has increased in recent years.Due to the improvement of the quality of life of modern patients,their willingness to treat has become more and more prominent.With the development of vascular surgical instruments,endovascular treatment has leading position.Recently,Drug-eluting stents have achieved positive therapeutic effects in the coronary atherosclerotic diseases field,but it is in its early stage in the treatment of PAD.In this study,a porcine peripheral artery restenosis model was used to verify the safety and efficacy of the new drug eluting stent.A model of porcine peripheral artery stenosis was established by overexpansion injury.To verify the feasibility of animal models and understand the safety of fluoride coated sirolimus drug-eluting stents tentatively by pre-experiment.The results showed:1.There were obvious endovascular tear and inflammation which are the basis of restenosis in later stage after acute overexpansion injury,and the model was successfully established.2.It indicates that the fluoride coating implanted in the animal body has antithrombotic and low inflammatory properties within a short period.And then the models of peripheral artery stenosis were established in 21 animals according to the experimental design.This research which was randomized controlled grouping trial used bare metal stents of the same manufacturer and the same type as control.The efficacy of fluoride-coated sirolimus eluting stent in inhibiting neointimal hyperplasia and safety were evaluated in 30 days,90 days and 180 days.The main evaluation methods were Quality vascular angiography(QVA)、histopathology and scanning electron microscope,the safety endpoints were the main organs,the degree of endothelialization,injury scores and inflammation scores,the effective endpoints were minimal lumen diameter,lumen loss(LL),neointima area,percentage of area stenosis.In conclusion,fluoride-coated sirolimus-eluting stents have good safety and can effectively inhibit neointimal hyperplasia.In this study,the porcine peripheral arterial stenosis model established by the over-expansion of the stent was used to verify the fluoride-coated sirolimus-eluting stent developed by domestic enterprises.It is safe to prevent thrombosis and low inflammation after implantation and effectiveness of inhibiting neointimal proliferation,which provided theoretical basis to solve re-stenosis and re-occlusion after endovascular treatment in PAD by this new eluting stent.