End Stage Renal DiseaseNCT06329310
Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study
A study testing aXess-E conduit in people with End Stage Renal Disease, run by Xeltis at 2 sites in 2 countries.
Trial summary
A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, 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?
- aXess-E conduit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Dec 2024to Dec 2028
- 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 Arteriovenous Graft (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-E conduit
- The patient has been informed about the nature of the study, understands and agrees to its provisions, and has personally 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 (New York Heart Association (NYHA) Functional Class IV and/or Ejection Fraction (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/ conduit 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
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- 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 conduit implantation
- Previous dialysis access conduit in the operative limb unless the aXess-E conduit can be placed more proximally than the previous failed conduit
- 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-E conduit (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Portugal1 site, 1 recruiting
- Recruiting
Hospital de Santa Maria
Lisbon
Augusto Ministro
Serbia1 site, 1 recruiting
- Recruiting
Kliničko bolnički centar Zvezdara Klinika za Interne Bolesti
Belgrade
Marijana Bogosavac
About this study
Official title: Prospective, Non-randomized Feasibility Study to Confirm the Safety and Performance of the Xeltis Hemodialysis Access Conduit: aXess-E Study
A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, 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
- aXess-E conduit
- 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.
aXess-E conduitDevice
The aXess-E 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-E conduit 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-E conduit | Experimental | Not described Receives: Device: aXess-E conduit |
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 Serious Adverse Event (SAE)
Measured: 6 months
Secondary outcomes (12)
Implantation success rate
Defined as a technically successful aXess-E conduit implantation in the planned configuration, free from kinking and tension in the anastomoses.
Measured: 1 day, from moment of implant until end of procedure day
Primary patency rate
Primary patency: Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.
Measured: 6, 12, 18, and 24 months
Primary assisted patency rate
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.
Measured: 6, 12, 18, and 24 months
Secondary patency rate
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).
Measured: 6, 12, 18, and 24 months
Functional patency rate
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, and 24 months
Time (expressed in months) to first intervention and to access abandonment
Measured: 24 months
Rate of access-related interventions required to achieve/maintain patency
Measured: 6, 12, 18, and 24 months
Freedom from device-related SAE
Measured: 12, 18, and 24 months
Rate of access site infections
Measured: 6, 12, 18, and 24 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: 24 months
Time to first cannulation
Assessed only in subjects who are already on dialysis at the time of implant.
Measured: 24 months
Following first cannulation, number of days with CVC in situ (catheter contact time) 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 Mar 2024
- Study start16 Dec 2024
- Primary completionJul 2027 (estimated)
- Study completionDec 2028 (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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xeltis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329310
- Sponsor's protocol ID
- XEL-CR-14
- Status last verified
- Jul 2026
- First submitted
- 18 Mar 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-randomized Feasibility Study to Confirm the Safety and Performance of the Xeltis Hemodialysis Access Conduit: aXess-E Study
- ClinicalTrials.gov ID
- NCT06329310
- Acronym / sponsor ID
- XEL-CR-14
- Conditions
- End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- XeltisIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Mar 2024 (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 feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, 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-E conduit | Experimental | Device: aXess-E conduit |
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 Arteriovenous Graft (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-E conduit
- The patient has been informed about the nature of the study, understands and agrees to its provisions, and has personally 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 (New York Heart Association (NYHA) Functional Class IV and/or Ejection Fraction (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/ conduit 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 |
|---|---|---|
| aXess-E conduitThe aXess-E 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-E conduit is able to support both straight and loop configurations and may be implanted in the upper arm and forearm. | Device | aXess-E conduit |
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 Serious Adverse Event (SAE)
Time frame: 6 months
12 secondary outcomes
Implantation success rate
Time frame: 1 day, from moment of implant until end of procedure day
Primary patency rate
Time frame: 6, 12, 18, and 24 months
Primary assisted patency rate
Time frame: 6, 12, 18, and 24 months
Secondary patency rate
Time frame: 6, 12, 18, and 24 months
Functional patency rate
Time frame: 6, 12, 18, and 24 months
Time (expressed in months) to first intervention and to access abandonment
Time frame: 24 months
Rate of access-related interventions required to achieve/maintain patency
Time frame: 6, 12, 18, and 24 months
Freedom from device-related SAE
Time frame: 12, 18, and 24 months
Rate of access site infections
Time frame: 6, 12, 18, and 24 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: 24 months
Time to first cannulation
Time frame: 24 months
Following first cannulation, number of days with CVC in situ (catheter contact time) 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 29 Jul 2026.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aXess-E conduit in people with End Stage Renal Disease, run by Xeltis at 2 sites in 2 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: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal, Serbia. 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?
Contact Eliane Schutte (+31 40 751 7614, clinical@xeltis.com), or a site near the patient. 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 29 Jul 2026.