Xeltis Hemodialysis Access Graft: aXess Pivotal Study

NAActive, not recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

November 4, 2022

Primary Completion Date

June 23, 2025

Study Completion Date

December 31, 2029

Conditions
End-stage Renal Disease
Interventions
DEVICE

Xeltis Hemodialysis Access (aXess) graft

The aXess graft is a sterile, regenerative biodegradable polymer-based vascular graft, consisting of a tubular structure with a 6mm inner diameter. It is comprised of a highly porous polymer matrix and an embedded electropolished nitinol reinforcement layer (Strain Relief System). The aXess graft is able to support both straight and loop configurations and may be implanted in the upper arm and forearm.

Trial Locations (22)

Unknown

AZ Sint Jan Brugge, Bruges

ZOL Genk, Genk

UZ Ghent, Ghent

Universitätsklinikum Köln, Cologne

LAIKO General Hospital of Athens, Athens

University General Hospital of Patras, Pátrai

Ospedali Riuniti Torrette di Ancona, Ancona

Policlinico di Bari, Bari

Policlinico di Sant'Orsola, Bologna

Università degli studi di Padova / Azienda ospedaliera di Padova, Padua

Universita degli studi dell'Insubria, Varese

Pauls Stradins Clinical University Hospital, Riga

Private hospital MedPolonia Poznan, Poznan

The Lower Silesia Center of Heart Diseases MEDINET, Wroclaw

Santa Maria Hospital, Lisbon

Grupo de Estudos Vasculares, Porto

DaVita Sacavém, Sacavém

Bellvitge University Hospital, Barcelona

Hospital Clínic de Barcelona, Barcelona

Hospital Universitario de la Ribera, Valencia

University Hospitals Birmingham - QE, Birmingham

Queen Elizabeth University Hospital, Glasgow

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Xeltis

INDUSTRY