End-stage Renal DiseaseNCT05473299
Xeltis Hemodialysis Access Graft: aXess Pivotal Study
A study testing Xeltis Hemodialysis Access (aXess) graft in people with End-stage Renal Disease, run by Xeltis at 22 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Xeltis Hemodialysis Access (aXess) graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 22 sitesin 9 countries
- Study dates
- 4 Nov 2022to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with end-stage renal disease (ESRD) who require placement of an AVG in the upper extremity to start or maintain hemodialysis therapy
- At least 18 years of age at screening
- Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an aXess graft
- The patient, or legal representative, has been informed about the nature of the study, agrees to its provisions, and has provided written informed consent
- The patient has been informed and agrees to pre- and post- procedure follow-up
- Life expectancy of at least 12 months
Who cannot join
- History or evidence of severe cardiac disease (NYHA Functional Class IV and/or EF <25%), myocardial infarction within six months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
- Uncontrolled or poorly controlled diabetes
- Abnormal blood values that could influence patient recovery and or/ graft hemostasis
- Reduced liver function, defined as: >2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) >1.5 or prothrombin time (PT) >18 seconds
- Any active local or systemic infection
- Known heparin-induced thrombocytopenia
Show all 17Show fewer
- Known active bleeding disorder and/or any coagulopathy or thromboembolic disease
- Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically
- Anticipated renal transplant within 6 months
- Known or suspected central vein obstruction on the side of planned graft implantation
- Previous dialysis access graft in the operative limb unless the aXess graft can be placed more proximally than the previous failed graft
- Previous enrolment in this study
- Subject is participating in another study
- Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
- Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit
- Intra-operative exclusion criteria:
- 1. Unsuitable anatomy to implant the aXess graft (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)
Trial locations and contacts
22 sites in 9 countries.
22 sites in 9 countries
Italy5 sites
Ospedali Riuniti Torrette di Ancona
Ancona
Policlinico di Bari
Bari
Policlinico di Sant'Orsola
Bologna
Università degli studi di Padova / Azienda ospedaliera di Padova
Padova
Universita degli studi dell'Insubria
Varese
Portugal3 sites
Santa Maria Hospital
Lisbon
Grupo de Estudos Vasculares
Porto
DaVita Sacavém
Sacavém
Spain3 sites
Bellvitge University Hospital
Barcelona
Hospital Clínic de Barcelona
Barcelona
Hospital Universitario de la Ribera
Valencia
Greece2 sites
LAIKO General Hospital of Athens
Athens
University General Hospital of Patras
Pátrai
Poland2 sites
Private hospital MedPolonia Poznan
Poznan
The Lower Silesia Center of Heart Diseases MEDINET
Wroclaw
United Kingdom2 sites
University Hospitals Birmingham - QE
Birmingham
Queen Elizabeth University Hospital
Glasgow
About this study
Official title: Prospective, Non-randomized Pivotal Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft: aXess Pivotal Study
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
- Being tested
- Xeltis Hemodialysis Access (aXess) graft
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xeltis Hemodialysis Access (aXess) graftDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| aXess graft | Experimental | Not described Receives: Device: Xeltis Hemodialysis Access (aXess) graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency rate
Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.
Measured: 6 months
Freedom from device-related SAE during the first 6 months
Measured: up to 6 months
Secondary outcomes (9)
Implantation success rate
Defined as a technically successful aXess graft implantation in the planned configuration, free from kinking and tension in the anastomoses. This is assessed at the procedure day itself.
Measured: 1 day, from moment of implant until end of procedure day
Patency (primary, primary assisted, secondary, and functional) rates
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 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 the functionality the vascular access, including occurrence of a censored event (death, change of modality, loss of follow-up).
Functional patency: Defined as the interval between first cannulation and abandonment, including occurrence of a censored event (death, change of modality, loss of follow-up).
Measured: 6, 12, 18, 24 and 60 months
Time (expressed in months) to first intervention and to access abandonment
Measured: 60 months
Rate of access-related interventions required to achieve/maintain patency
Measured: 6, 12, 18, 24, and 60 months
Freedom from device-related SAE
Measured: 12, 18, 24, and 60 months
Rate of access site infections
Measured: 6, 12, 18, 24, and 60 months
Proportion of hemodialysis sessions completed via central venous catheter (CVC) during the first 12 months of access creation and access cannulation, irrespective of access abandonment
Measured: 12 months
Time to first cannulation
Measured: 12 months
Following first cannulation, number of days with CVC in situ (catheter contact time) during the first 12 months, irrespective of access abandonment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start4 Nov 2022
- Primary completion23 Jun 2025
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xeltis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mauro Gargiulo, Prof, Principal investigator, Policlinico di Sant'OrsolaAn de Vriese, Dr, Principal investigator, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473299
- Sponsor's protocol ID
- XEL-CR-10
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2022
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-randomized Pivotal Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft: aXess Pivotal Study
- ClinicalTrials.gov ID
- NCT05473299
- Acronym / sponsor ID
- XEL-CR-10
- Conditions
- End-stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- XeltisIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 23 Jun 2025 (actual)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aXess graft | Experimental | Device: Xeltis Hemodialysis Access (aXess) graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with end-stage renal disease (ESRD) who require placement of an AVG in the upper extremity to start or maintain hemodialysis therapy
- At least 18 years of age at screening
- Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an aXess graft
- The patient, or legal representative, has been informed about the nature of the study, agrees to its provisions, and has provided written informed consent
- The patient has been informed and agrees to pre- and post- procedure follow-up
Key exclusion criteria (17 listed)
- History or evidence of severe cardiac disease (NYHA Functional Class IV and/or EF <25%), myocardial infarction within six months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
- Uncontrolled or poorly controlled diabetes
- Abnormal blood values that could influence patient recovery and or/ graft hemostasis
- Reduced liver function, defined as: >2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) >1.5 or prothrombin time (PT) >18 seconds
- Any active local or systemic infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xeltis Hemodialysis Access (aXess) graftThe 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. | Device | aXess graft |
Primary outcome
Primary patency rate
Time frame: 6 months
Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.
Freedom from device-related SAE during the first 6 months
Time frame: up to 6 months
9 secondary outcomes
Implantation success rate
Time frame: 1 day, from moment of implant until end of procedure day
Patency (primary, primary assisted, secondary, and functional) rates
Time frame: 6, 12, 18, 24 and 60 months
Time (expressed in months) to first intervention and to access abandonment
Time frame: 60 months
Rate of access-related interventions required to achieve/maintain patency
Time frame: 6, 12, 18, 24, and 60 months
Freedom from device-related SAE
Time frame: 12, 18, 24, and 60 months
Rate of access site infections
Time frame: 6, 12, 18, 24, and 60 months
Proportion of hemodialysis sessions completed via central venous catheter (CVC) during the first 12 months of access creation and access cannulation, irrespective of access abandonment
Time frame: 12 months
Time to first cannulation
Time frame: 12 months
Following first cannulation, number of days with CVC in situ (catheter contact time) during the first 12 months, irrespective of access abandonment
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for End-stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauro Gargiulo, Prof principal investigator
Policlinico di Sant'Orsola
An de Vriese, Dr principal investigator
AZ Sint-Jan AV
22 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xeltis Hemodialysis Access (aXess) graft in people with End-stage Renal Disease, run by Xeltis at 22 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Italy, Belgium, Portugal, Spain, Greece and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency rate (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.