Abstract：
UNASSIGNED: The creation of an arteriovenous fistula (AVF) is considered the most effective hemodialysis (HD) vascular access. For patients who are not suitable for AVF, arteriovenous grafts (AVGs) are the best access option for chronic HD. However, conventional AVGs are prone to intimal hyperplasia, stenosis, thrombosis, and infection. Xeltis has developed an AVG as a potential alternative to currently available AVGs based on the concept of endogenous tissue restoration. The results of the first 6-month follow-up are presented here.
UNASSIGNED: The aXess first-in-human (FIH) study [NCT04898153] is a prospective, single-arm, multicenter feasibility study that evaluates the early safety and performance of the aXess Hemodialysis Graft. A total of 20 patients with end-stage renal disease were enrolled across six European investigational sites.
UNASSIGNED: At 6-months follow-up, all grafts were patent with primary and secondary patency rates were 80% and 100%, respectively. Three patients required a re-intervention to maintain graft patency, while one re-intervention was required to restore patency. One graft thrombosis and zero infections were reported.
UNASSIGNED: The expected advantages of the novel aXess Hemodialysis Graft over conventional AVGs would be evaluated by the analysis on long-term safety and effectiveness during the 5-year follow-up of the currently ongoing trial.
UNASSIGNED: The aXess first-in-human (FIH) study [NCT04898153] is a prospective, single-arm, multicenter feasibility study that evaluates the early safety and performance of the aXess Hemodialysis Graft. A total of 20 patients with end-stage renal disease were enrolled across six European investigational sites.
UNASSIGNED: At 6-months follow-up, all grafts were patent with primary and secondary patency rates were 80% and 100%, respectively. Three patients required a re-intervention to maintain graft patency, while one re-intervention was required to restore patency. One graft thrombosis and zero infections were reported.
UNASSIGNED: The expected advantages of the novel aXess Hemodialysis Graft over conventional AVGs would be evaluated by the analysis on long-term safety and effectiveness during the 5-year follow-up of the currently ongoing trial.
摘要：
■动静脉瘘(AVF)的形成被认为是最有效的血液透析(HD)血管通路。对于不适合AVF的患者，动静脉移植物（AVG）是慢性HD的最佳途径。然而,常规AVG容易发生内膜增生，狭窄,血栓形成,和感染。Xeltis基于内源性组织恢复的概念，开发了AVG作为当前可用AVG的潜在替代品。第一个6个月随访的结果在这里介绍。
■人类首次（FIH）研究[NCT04898153]是一项前瞻性研究，单臂,评估aXess血液透析移植物早期安全性和性能的多中心可行性研究。共有20名终末期肾病患者被纳入6个欧洲研究中心。
■在6个月的随访中，所有移植物均为专利，一级和二级通畅率分别为80％和100％，分别。三名患者需要重新干预以维持移植物通畅，而恢复通畅需要一次重新干预。报告了1例移植物血栓形成和零感染。
新型aXess血液透析移植物优于常规AVG的预期优势将通过对目前正在进行的试验的5年随访期间的长期安全性和有效性分析来评估。
■人类首次（FIH）研究[NCT04898153]是一项前瞻性研究，单臂,评估aXess血液透析移植物早期安全性和性能的多中心可行性研究。共有20名终末期肾病患者被纳入6个欧洲研究中心。
■在6个月的随访中，所有移植物均为专利，一级和二级通畅率分别为80％和100％，分别。三名患者需要重新干预以维持移植物通畅，而恢复通畅需要一次重新干预。报告了1例移植物血栓形成和零感染。
新型aXess血液透析移植物优于常规AVG的预期优势将通过对目前正在进行的试验的5年随访期间的长期安全性和有效性分析来评估。
