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In vivo evaluation of safety and performance of a tapered nitinol venous stent with inclined proximal end in an ovine iliac venous model

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机构: [1]Capital Med Univ, Xuanwu Hosp, Dept Vasc Surg, 45 Changchun St, Beijing 100053, Peoples R China [2]Shandong First Med Univ, Affiliated Hosp 1, Vasc Surg, Jinan, Peoples R China [3]Capital Med Univ, Xuanwu Hosp, Gen Surg, Beijing, Peoples R China [4]ShenZhen KYD Biomed Technol Co Ltd, Guangzhou, Peoples R China
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关键词: Iliac vein Iliocaval venous obstruction Venous insufficiency Venous stent

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A tapered stent with inclined proximal end is designed for fitting the iliac anatomically. The aim of the present study was to evaluate the safety and performance of the new stent in ovine left iliac veins. The experiment was performed in 30 adult sheep, and one nitinol-based VENA-BT (R) iliac venous stent (KYD stent) was implanted into each animal's left common iliac vein. Follow-up in all sheep consisted of angiographic, macroscopic, and microscopic examinations at Day 0 (< 24 h), Day 30, Day 90, Day 180 and Day 360 post-stenting (six animals per each time-point). 30 healthy similar to 50 kg sheep were included in this study and randomly divided into five groups according to the follow-up timepoint. All stents were implanted successfully into the left ovine common iliac vein. No significant migration occurred at follow-up. There is no statistically significant difference between the groups (p > 0.05), indicating no serious lumen loss occurred during the follow-up period. Common iliac venous pressure was further measured and the results further indicated the lumen patency at follow-up. Histological examinations indicated that no vessel injury and wall rupture, stent damage, and luminal thrombus occurred. There was moderate inflammatory cell infiltration around the stent in Day-0 and Day-30 groups with the average inflammation score of 2.278 and 2.167, respectively. The inflammatory reaction was significantly reduced in Day-90, Day-180 and Day-360 groups and the average inflammation scores were 0.9444 (p < 0.001, Day-90 vs Day-0), 1.167 (p < 0.001, Day-180 vs Day-0) and 0.667 (p < 0.001, Day-90 vs Day-0), respectively. The microscopic examinations found that the stents were well covered by endothelial cells in all follow-up time points. The results suggested that the KYD stent is feasible and safe in animal model. Future clinical studies may be required to further evaluate its safety and efficacy.

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出版当年[2023]版:
大类 | 2 区 综合性期刊
小类 | 2 区 综合性期刊
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大类 | 2 区 综合性期刊
小类 | 2 区 综合性期刊
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Q2 MULTIDISCIPLINARY SCIENCES
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Q1 MULTIDISCIPLINARY SCIENCES

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第一作者机构: [1]Capital Med Univ, Xuanwu Hosp, Dept Vasc Surg, 45 Changchun St, Beijing 100053, Peoples R China
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