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.
■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。