Objective: Animal experiments and clinical trials were carried out to evaluate the efficiency of a new stent for the treatment of iliac vein stenosis. Methods: The new iliac vein stent and the control stent were implanted, respectively, into the 12 experimental pigs. Digital Subtraction Angiography was done separately at the same day, 14th, 30th, 60th and 90th day after stent implantation to observe the stent deployment. One patient was implanted with a new iliac vein stent. Digital subtraction angiography (DSA) was done after the operation to calculate the lumen loss value and lumen loss rate of the stent and evaluate the performance of the new iliac vein stent at 12 months of follow-up. Results: The mechanical experiment and finite element analysis of the stent proved that the radial support force of the new stent is significantly better than that of the control stent. In animal experimental verification, both groups of stent were released satisfactorily during implantation. No obvious stent displacement was found at each time point. The patency rate of stents was 100%. Except for a small amount of old thrombosis in the stent in the control group, no other stents were found in that condition. The diameter of the stent lumen was retracted in different degrees in both groups after the operation, but no significant statistical difference was found in the comparison of the stent lumen loss rate at each relative inspection day. Conclusion: The new nickel-titanium alloy iliac vein stent has excellent radial support performance, which may be an ideal iliac vein stent.

中文翻译：

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髂静脉狭窄治疗专用支架的性能测试与实验研究

目的：通过动物实验和临床试验评价新型支架治疗髂静脉狭窄的疗效。方法：将新型髂静脉支架和对照支架分别植入12头实验猪体内。在支架植入后的同一天、第14天、第30天、第60天和第90天分别进行数字减影血管造影，观察支架展开情况。一名患者植入了新的髂静脉支架。术后进行数字减影血管造影（DSA），计算支架的管腔损失值和管腔损失率，并评估新髂静脉支架在随访12个月时的性能。结果：支架的力学实验和有限元分析证明，新支架的径向支撑力明显优于对照支架。在动物实验验证中，两组支架在植入过程中均获得了满意的释放。各时间点均未发现明显支架移位。支架通畅率为100%。除对照组支架内有少量陈旧血栓外，未发现其他支架。术后两组支架管腔直径均有不同程度的回缩，但各相关检查日支架管腔丢失率比较差异无统计学意义。结论：新型镍钛合金髂静脉支架具有优良的径向支撑性能，