关键词: 透析通路, 流出道静脉狭窄, 覆膜支架

Abstract: Objective:To evaluate the safety and efficacy of the dometic SINUOUS heparin-coated stent graft in treating stenosis or occlusion of the hemodialysis access outflow vein. Methods:A prospective,multicenter,single-arm study was conducted,with 151 patients enrolled.The primary endpoint was the target lesion primary patency (TLPP) at 12 months postoperation.The safety was also assessed. Results:The device and procedural success rates were 100%.The TLPP at 12 months was 54.67% in the full analysis set and 58.16% in the per-protocol set.Device-related serious adverse events was 6.00%,and all deaths were unrelated to the device. Conclusion:The SINUOUS heparin-coated stent graft demonstrated good efficacy and safety with patency comparable to those of similar imported devices.The subgroup analysis showed a better efficacy in cases of arteriovenous fistula and central venous lesions,providing a reference for individualized clinical treatment.It is of great significance for the domestic substitution.