The Preclinical Study Of A Novel Self-expanding Dedicated Venous Stent Based On Human CT Image Data

Iliac venous obstruction(IVO)is a common cause of chronic venous disease(CVD)and acutedeep venous thrombosis of lower extremities.Percutaneous stentinghas become a preferred treatment because it is minimally invasive and has a high safety profile.However,currently used stents were primarily designed for arterial indications,and their structural parameters are mainly based on the anatomical features of foreign populations may not be optimal for use in patients with venous diseases in China.Based on the CT data of human patients in China,this study designed a new self-expanding stent for venous diseases and conducted preclinical studies to verify its safety and feasibility.This study includes three sections.Section One,analysis of imaging data of human iliac veins.This retrospective cross-sectional observational study included 183 consecutive patients who underwent Computed tomography venography(CTV)at the first hospital of Hebei Medical University between 1 January 2016 and 31 December 2016 with a diagnosis of CVD.Patients5 baseline characteristic,morphological features were collected based on electronic patient record CTV scans.The association between morphological features and clinical features was explored.Section two,experiment of in vitro mechanical properties of venous stents.Combined with the results of the section one,the research team and the domestic manufacturers cooperated to develop a dedicated,self-expanding venous stent featuring a hybrid structure and oblique plane.This section is an in vitro analysis of its mechanical properties.The mechanical properties of the whole and different segments were studied and compared with other venous stents.It is confirmed that the hybrid structure is designed to meet the mechanical requirements in the treatment of venous diseases.Section three,in vivo experiment of the venous stent in animals.The safety and feasibility of the stent and delivery system were evaluated in canine iliac venous model.The simulation operation in the animals confirmed that the stent and the delivery system have high safety and feasibility during the procedure.The results at follow-up time of 30 days,90 days,and 180 days,showed that the patency of the stent can meet the clinical needs.