中文摘要：

目的通过动物实验研究,探讨国产雷帕霉素-肝素洗脱支架（DES）的顺应性、可视性、定位准确性及预防再狭窄性能。方法实验支架28枚（12枚雷帕霉素-肝素洗脱支架,8枚雷帕霉素洗脱支架,8枚裸支架）分别置入14条犬中。严格抗凝后,7只犬30天造影观察后处死,另7只犬60天造影观察后处死。分别观察支架顺应性、可视性、定位准确性;测定支架体内药代动力学特点;测量支架段直径,参考节段内直径,晚期丢失,血栓形成,支架内再狭窄率,参考节段内再狭窄率。结果进行统计分析。结果28枚支架位置良好,无移位、脱落。雷帕霉素-肝素DES支架具有良好的顺应性,X线下可视性较强,定位准确。雷帕霉素-肝素DES释放时即刻雷帕霉素药物浓度在1.79～2.22ng/ml之间,7天左右达到0.4ng/ml,可持续释放12周左右。7只犬术后30天造影,显示支架管腔通畅,无血栓形成或管腔狭窄发生。7只犬术后60天造影,显示2枚雷帕霉素支架血栓性闭塞,1枚雷帕霉素-肝素DES支架和3枚裸支架不同程度狭窄,1枚雷帕霉素-肝素DES近端可见血管轻度凹陷。雷帕霉素-肝素支架与雷帕霉素支架、裸支架支架段直径间有差别,差别有统计学意义（F=0.049,P〈0.05）。雷帕霉素-肝素支架与雷帕霉素支架、裸支架间支架段直径晚期丢失有差别,差别有统计学意义（F=0.047,P〈0.05）。结论国产雷帕霉素-肝素洗脱支架具有良好的顺应性,X线下可视性较强,标记清楚,释放时无明显回缩或前跳;国产雷帕霉素-肝素洗脱支架具有一定的抗凝性能及预防再狭窄能力。

英文摘要：

Objective To evaluate the plasticity, visibility, positioning accuracy and features of inhibition of in-stent restenosis in the china-made peripheral arterial sirolimus-heparin eluting stent. Methods Twelve sirolimus-heparin eluting stents, 8 sirolimus eluting stents and 8 bare stents were implanted into peripheral arteries of 14 dogs, which were accepted strictly anticoagulation. Seven dogs were killed after 30 days, another 7 dogs were killed after 60 days. The plasticity, visibility, radial force, position features of sirolimus-heparin eluting stents were investigated, and in-stent thrombosis, in-stent diameter, reference segment diameter, late loss of lumina and in-stent restenosis rate of the eluting stent were evaluated mainly. Results The whole 28 stents were successfully implanted into dogs＇ peripheral arteries without complication. The stents had satisfactory plasticity, good visibility and accurate position. The concentration of sirolimus was 1.79-2. 22 ng/ml immediately after stent implantation, and was 0. 4 ng/ml at 7 days and was continuously releasing about 12 weeks. The imaging following up indicated no thrombosis and intimal hyperplasy at 30 days. Sixty days later, 2 sirolimus stents occurred obstruction due to obvious thrombosis; 1 sirolimus-heparin stent and 3 bare stent occurred intimal hyperplasy. One stent was found hollow in the segment proximate to sirolimus-heparin stent. There were differences in in-stent diameter among sirolimus-heparin stent, sirolimus stent and bare stent, and the difference had statistical significance （F= 0. 049, P〈0. 05）. There were differences in in-stent diameter late loss among sirolimus-heparin stent, sirolimus stent and bare stent,and the difference had statistical significance （F=0. 047,P〈0. 05）. Conclusion The china-made peripheral sirolimus-heparin eluting stent had good plasticity and Visibility to X-ray. There＇s no recovery and skip during implantation. The sirolimus-heparin eluting stent of peripheral artery could provid a strong radial fo