End Stage Renal DiseaseaXess-FIHNCT04898153
First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft
A study testing aXess in people with End Stage Renal Disease and End Stage Renal Failure on Dialysis, run by Xeltis at 6 sites in 4 countries.
Trial summary
A feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, End Stage Renal Failure on Dialysis
- What is being tested?
- aXess
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 10 Jun 2021to Sep 2027
- 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 older than 18 years with end-stage renal disease (ESRD) who are not, or who are no longer, candidates for creation of an autogenous AV fistula, and therefore require placement of an AV graft in the upper extremity to start or maintain hemodialysis therapy
- Suitable anatomy for the implantation of an aXess graft
- The patient 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 (NHYA Functional Class IV and/or EF <30%), myocardial infarction within six months of study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
- Stroke within six months before study entry
- Active clinically significant autoimmune / inflammatory disease, immunodeficiency (including AIDS / HIV), use of immunosuppressive therapy or medication that likely interferes with restorative therapies
- Abnormal blood values (e.g. leurkopenia with white blood cell (WBC) count < 4,000/mm3 and/or anemia with hemoglobin <8g/dL and/or thrombocytopenia < 100,000/mm3) that could influence patient recovery and/or graft hemostasis
- Any active local or systemic infection (WBC > 15,000/mm3)
- Uncontrolled or poorly controlled diabetes (hemoglovin A1c > 8% despite standard care) or hospitalization for poor glucose control within the previous 6 months
Show all 20Show fewer
- Reduced liver function, defined as: >2x the upper limit of normal for serum bilirubin, aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase; International Normalized Ratio (INR) > 1.5 or prothrombin time (PT) > 18 seconds
- Known heparin-induced thrombocytopenia
- Active bleeding disorder and/or any coagulopathy or thrombo embolic disease
- History or evidence of severe peripheral vascular disease in the upper limbs
- 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
- More than 1 failed dialysis access graft in the operative limb
- Anticipated renal transplant within 6 months
- Subjects receiving a forearm graft which crosses the elbow
- Allergies to study device (Nitinol) or agents/medication, such as contrast agents, aspirin, or clopidogrel, that cant be controlled medically
- Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
- Subject is participating in another study
- Previous enrollment in this study
- Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and efficacy of the study conduit
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Lithuania1 site
Vilnius University Hospital Santaros Klinikos Corpus A.
Vilnius
About this study
Official title: First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft (aXess)
A feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.
Read the detailed description
A prospective, single arm, non-randomized FIH feasibility study to evaluate the preliminary 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, and are deemed not suitable for fistula creation by the operating surgeon.
- Being tested
- aXess
- 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.
aXessDevice
Patients will be implanted with one Xeltis hemodialysis access device (aXess) in the arm
| Study group | Role | What they receive |
|---|---|---|
| aXess | Experimental | Patients will be implanted with the Xeltis hemodialysis access graft (aXess) Receives: Device: aXess |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from device related serious adverse events
The number of patients who have a device related serious adverse event
Measured: 6 months
Functional patency of graft
The number of patients with a functionally patent graft
Measured: 6 months
Secondary outcomes (10)
Freedom from device related serious adverse events
The number of patients who have a device related serious adverse event
Measured: 12, 18, 24, and 60 months
Functional patency of graft
The number of patients with a functionally patent graft
Measured: 12, 18, 24, and 60 months
Patency (primary, primary assisted, and secondary) of graft
The number of patients with a patient graft
Measured: 6, 12, 18, 24, and 60 months
Time to potential central venous catheter removal
Time that patients with a central venous catheter could have had the catheter removed after the Xeltis hemodialysis access graft was placed
Measured: Assessed retrospectively at 30 days
Time to loss of patency (primary, primary assisted, and secondary)
Number of days from implant to graft occlusion in patients who no longer have a patent graft
Measured: 6, 12, 18, 24, and 60 months
Rate of access related interventions required to achieve/maintain patency
Number of interventions that were performed on grafts to achieve/maintain patency
Measured: 6, 12, and 24 months
Rate of access site infections
Number of access graft sites that become infected
Measured: 6, 12, and 24 months
Proportion of hemodialysis (HD) sessions completed via central venous catheter
Number of hemodialysis sessions performed with a central venous catheter vs. the number of sessions performed with the Xeltis hemodialysis access graft
Measured: 12 months
Number of days with central venous catheter in place (catheter contact time)
Number of days the patients have a central venous catheter in place irrespective of access abandonment
Measured: 12 months
Pseudoaneurysm formation
Number of grafts that have a pseudoaneurysm form
Measured: 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start10 Jun 2021
- Primary completion24 Mar 2023
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xeltis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Vermassen, MD, Principal investigator, UZ Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898153
- Sponsor's protocol ID
- XEL-CR-08
- Acronym
- aXess-FIH
- Status last verified
- Jul 2025
- First submitted
- 13 Apr 2021
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tozzi M, De Letter J, Krievins D, Jushinskis J, D'Haeninck A, Rucinskas K, Miglinas M, Baltrunas T, Nauwelaers S, Schoen FJ, Virmani R, De Vriese AS, Moll F, Vermassen F. Endogenous tissue restoration in a hemodialysis conduit: Performance and safety after 1-year of follow-up. J Vasc Access. 2026 May;27(3):1234-1244. doi: 10.1177/11297298251395823. Epub 2025 Nov 21.
PubMed 41272425
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft (aXess)
- ClinicalTrials.gov ID
- NCT04898153
- Acronym / sponsor ID
- aXess-FIH / XEL-CR-08
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- XeltisIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 May 2021 (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 feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.
Detailed description
A prospective, single arm, non-randomized FIH feasibility study to evaluate the preliminary 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, and are deemed not suitable for fistula creation by the operating surgeon.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aXess | Experimental | Device: aXessPatients will be implanted with the Xeltis hemodialysis access graft (aXess) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects older than 18 years with end-stage renal disease (ESRD) who are not, or who are no longer, candidates for creation of an autogenous AV fistula, and therefore require placement of an AV graft in the upper extremity to start or maintain hemodialysis therapy
- Suitable anatomy for the implantation of an aXess graft
- The patient 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
Key exclusion criteria (20 listed)
- History or evidence of severe cardiac disease (NHYA Functional Class IV and/or EF <30%), myocardial infarction within six months of study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
- Stroke within six months before study entry
- Active clinically significant autoimmune / inflammatory disease, immunodeficiency (including AIDS / HIV), use of immunosuppressive therapy or medication that likely interferes with restorative therapies
- Abnormal blood values (e.g. leurkopenia with white blood cell (WBC) count < 4,000/mm3 and/or anemia with hemoglobin <8g/dL and/or thrombocytopenia < 100,000/mm3) that could influence patient recovery and/or graft hemostasis
- Any active local or systemic infection (WBC > 15,000/mm3)
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 |
|---|---|---|
| aXessPatients will be implanted with one Xeltis hemodialysis access device (aXess) in the arm | Device | aXess |
Primary outcome
Freedom from device related serious adverse events
Time frame: 6 months
The number of patients who have a device related serious adverse event
Functional patency of graft
Time frame: 6 months
The number of patients with a functionally patent graft
10 secondary outcomes
Freedom from device related serious adverse events
Time frame: 12, 18, 24, and 60 months
Functional patency of graft
Time frame: 12, 18, 24, and 60 months
Patency (primary, primary assisted, and secondary) of graft
Time frame: 6, 12, 18, 24, and 60 months
Time to potential central venous catheter removal
Time frame: Assessed retrospectively at 30 days
Time to loss of patency (primary, primary assisted, and secondary)
Time frame: 6, 12, 18, 24, and 60 months
Rate of access related interventions required to achieve/maintain patency
Time frame: 6, 12, and 24 months
Rate of access site infections
Time frame: 6, 12, and 24 months
Proportion of hemodialysis (HD) sessions completed via central venous catheter
Time frame: 12 months
Number of days with central venous catheter in place (catheter contact time)
Time frame: 12 months
Pseudoaneurysm formation
Time frame: 6, 12, and 24 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 10 Jul 2025.
- Derived from this study: PubMed 41272425Tozzi M, De Letter J, Krievins D, Jushinskis J, D'Haeninck A, Rucinskas K, Miglinas M, Baltrunas T, Nauwelaers S, Schoen FJ, Virmani R, De Vriese AS, Moll F, Vermassen F. Endogenous tissue restoration in a hemodialysis conduit: Performance and safety after 1-year of follow-up. J Vasc Access. 2026 May;27(3):1234-1244. doi: 10.1177/11297298251395823. Epub 2025 Nov 21.
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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.
Frank Vermassen, MD principal investigator
UZ Ghent
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aXess in people with End Stage Renal Disease and End Stage Renal Failure on Dialysis, run by Xeltis at 6 sites in 4 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 5 inclusion and 20 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 10 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 6 sites in Belgium, Italy, Latvia, Lithuania. 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?
Freedom from device related serious adverse events (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?
On the ClinicalTrials.gov record for NCT04898153, which also lists 1 linked publication.
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 10 Jul 2025.