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Xeltis Hemodialysis Access Graft: aXess Pivotal Study

NCT05473299 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-18

No results posted yet for this study

Summary

A prospective, single arm, non-randomized pivotal study to evaluate the safety and performance of the Xeltis hemodialysis access graft in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation.

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.

Sponsors & Collaborators

  • Xeltis

    lead INDUSTRY

Principal Investigators

  • Mauro Gargiulo, Prof · Policlinico di Sant'Orsola

  • An de Vriese, Dr · AZ Sint-Jan AV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-04
Primary Completion
2025-06-23
Completion
2029-12-31

Countries

  • Belgium
  • Germany
  • Greece
  • Italy
  • Latvia
  • Poland
  • Portugal
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05473299 on ClinicalTrials.gov