The journal of vascular access · 2025
Endogenous tissue restoration in a hemodialysis conduit: Performance and safety after 1-year of follow-up.
СтатьяМногоцентровое исследованиеКлиническое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Tozzi Matteo, De Letter Jan, Krievins Dainis, Jushinskis Janis, D'Haeninck Annick, Rucinskas Kestutis, Miglinas Marius, Baltrunas Tomas, Nauwelaers Sigi, Schoen Frederick J, Virmani Renu, De Vriese An S, Moll Frans, Vermassen Frank
Аннотация
BACKGROUND: Xeltis' aXess hemodialysis (HD) conduit is a novel arteriovenous graft (AVG) made of bioabsorbable polymer, replaced by body-own tissue, through endogenous tissue restoration (ETR).
METHODS: An ongoing prospective, single-arm, multi-center first-in-human (FIH) study evaluates safety and performance in hemodialysis patients unsuitable for arteriovenous fistula (AVF) creation. Primary and secondary 12-months outcomes are reported.
RESULTS: The aXess conduit was implanted in 20 patients. Freedom from device-related serious adverse events (SAEs) was 100% at 6 months and 95% at 12 months, with no access-related infections. Two unrelated deaths occurred. Primary and secondary patency rates were 80% and 100% at 6 months, 39% and 100% at 12 months. Access-related interventions occurred in 61% of patients, mainly for thrombosis and stenosis (71%), and pseudoaneurysms (29%). Histology showed remodeling at 6 months; the polymer was almost resorbed at 15 months.
CONCLUSIONS: This bioengineered conduit shows favorable safety and performance for 1 year. However, long-term validation in a pivotal trial is warranted.
TRIAL REGISTRATION: First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft (aXess-FIH) (https://www.
CLINICALTRIALS: gov); Unique identifier: NCT04898153.
METHODS: An ongoing prospective, single-arm, multi-center first-in-human (FIH) study evaluates safety and performance in hemodialysis patients unsuitable for arteriovenous fistula (AVF) creation. Primary and secondary 12-months outcomes are reported.
RESULTS: The aXess conduit was implanted in 20 patients. Freedom from device-related serious adverse events (SAEs) was 100% at 6 months and 95% at 12 months, with no access-related infections. Two unrelated deaths occurred. Primary and secondary patency rates were 80% and 100% at 6 months, 39% and 100% at 12 months. Access-related interventions occurred in 61% of patients, mainly for thrombosis and stenosis (71%), and pseudoaneurysms (29%). Histology showed remodeling at 6 months; the polymer was almost resorbed at 15 months.
CONCLUSIONS: This bioengineered conduit shows favorable safety and performance for 1 year. However, long-term validation in a pivotal trial is warranted.
TRIAL REGISTRATION: First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft (aXess-FIH) (https://www.
CLINICALTRIALS: gov); Unique identifier: NCT04898153.
Предметные рубрики MeSH
HumansRenal DialysisVascular PatencyProspective StudiesTime FactorsBlood Vessel ProsthesisTreatment OutcomeMaleMiddle AgedBlood Vessel Prosthesis ImplantationFemaleAgedProsthesis DesignArteriovenous Shunt, SurgicalAbsorbable ImplantsGraft Occlusion, VascularVascular RemodelingAdultPolymersUpper Extremity