Post Market Clinical Follow-Up Registry Study of the aXess Hemodialysis Conduit (aXess4All)

November 3, 2026 updated by: Xeltis

Prospective, Single Arm, Non-randomized PMCF Registry Study to Evaluate the Safety and Performance of the aXess Hemodialysis Conduit.

A prospective, single arm, non-randomized Post Market Clinical Follow-up (PMCF) registry study to evaluate the safety and performance of the aXess Hemodialysis Conduit, called aXess4All. Intended for Patients older than 18 years of age with end-stage renal disease who require a vascular access for hemodialysis, compliant with the Instructions for Use who consented in study participation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Patients older than 18 years of age with end-stage renal disease who require a vascular access for hemodialysis, compliant with the Instructions for Use who consented in study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aXess
Device: Xeltis aXess Hemodialysis Conduit

The aXess Hemodialysis Conduit is a sterile, regenerative biodegradable polymer-based vascular conduit, 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 Hemodialysis Conduit is able to support both straight and loop configurations and may be implanted in the upper arm or forearm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from major aXess infection
Time Frame: 12 months post-implant

Major aXess infection defined as conduit-related infections resulting in (partial) aXess Hemodialysis Conduit explantation.
12 months post-implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary, primary-assisted and secondary patency
Time Frame: 6, 12, 24, 36, 48 months post-implant

Primary patency: Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.

Assisted primary patency: Defined as the interval between vascular access creation and the first occlusion (thrombosis), including interventions (operative or endovascular) aimed to maintain the functionality of the vascular access.

Secondary patency: Defined as the interval between vascular access creation and abandonment with or without interventions (operative or endovascular) aimed to maintain or restore the functionality the vascular access, including occurrence of a censored event (death, change of modality, loss of follow-up).
6, 12, 24, 36, 48 months post-implant
Freedom from major aXess infection
Time Frame: 6, 24, 36, 48 months post-implant

Major aXess infection defined as conduit-related infections resulting in (partial) aXess Hemodialysis Conduit explantation.
6, 24, 36, 48 months post-implant
Rate of interventions to maintain or restore patency
Time Frame: 6, 12, 24, 36, 48 months post-implant
6, 12, 24, 36, 48 months post-implant
Rate of interventions to treat pseudoaneurysms
Time Frame: 6, 12, 24, 36, 48 months post-implant
6, 12, 24, 36, 48 months post-implant
Rate of treatment failures
Time Frame: Day 0 post-implant

Treatment failure defined as patients that had an implant attempted but are discharged without a functional aXess Hemodialysis Conduit
Day 0 post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xeltis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

November 3, 2026

First Submitted That Met QC Criteria

November 3, 2026

First Posted (Actual)

November 9, 2026

Study Record Updates

Last Update Posted (Actual)

November 9, 2026

Last Update Submitted That Met QC Criteria

November 3, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XEL-CR-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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