End Stage Renal DiseaseNCT06494631
Xeltis Hemodialysis Access Graft (aXess) US Study
A study testing Xeltis Hemodialysis Access (aXess) graft in people with End Stage Renal Disease, run by Xeltis at 7 sites in United States.
Trial summary
A multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min, who intend to… 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
- 140 participants
- Where
- 7 sitesUnited States
- Study dates
- 11 Nov 2024to Jan 2032
- 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 (within the first 6 months of follow-up) or maintain hemodialysis therapy and are deemed unsuitable for fistula creation by the investigational surgeon.
- At least 18 years of age at screening.
- Suitable anatomy (e.g. a target vein with a minimum diameter of 4mm) 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 (NYHA Functional Class IV and/or EF <25%), myocardial infarction within 6 months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina.
- Uncontrolled or poorly controlled diabetes in the opinion of the investigator. Recommended standards of A1c level <8% / 183 mg/dl / 10.2 eAG.
- Abnormal blood values (e.g., leukopenia with white blood cell count (WBC) <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.
- 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 graft implantation.
- Previous dialysis access graft in the operative limb, unless the aXess graft can be placed more proximally than the previously failed graft.
- Previous enrollment in this study.
- Subject is participating in another study.
- A female who is breastfeeding or of childbearing potential with a positive pregnancy test or not using adequate contraception.
- Any other condition which, in the judgment 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 not suitable; severe calcification).
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Surgical Specialists of Charlotte
Charlotte, North Carolina, 28210
Greenwood Leflore Hospital
Greenwood, Mississippi, 38930
Flow Vascular, Surgery Specialty Hospitals of America
Pasadena, Texas, 77504
AKDHC Medical Research Services, LLC
Phoenix, Arizona, 85016
Sarasota Memorial Hospital
Sarasota, Florida, 34239
AKDHC Medical Research Services, LLC
Tuscon, Arizona, 85718
About this study
Official title: Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft
A multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min, who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating surgeon.
- 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, restorative 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.
Secondary patency rate in survivors
Secondary patency is defined as the interval between vascular access creation and abandonment with or without interventions (operative or endovascular) aimed to maintain or restore the vascular access's functionality.
Patients who died or changed dialysis modality before 12 months will be excluded from the primary effectiveness analysis if loss of secondary patency was not observed before these events
Measured: 12 months
Rate of device related infections and bleeding
Infections are defined as: All device or procedure related infections potentially resulting from surgical manipulations or device cannulation, including both minor and major infections., Bleeding (procedure or device related bleeding, at least BARC 2) and device related hematoma defined as blood accumulation around the graft arising from the implantation or cannulation that triggered a medical or surgical action
Measured: 12 months
Secondary outcomes (10)
Freedom from device-related SAE
Measured: Discharge, 1, 3, 6, 12, 18, 24, and 60 months
Implantation success rate
Defined as a technically successful aXess graft implantation in the planned configuration, free from kinking and tension in the anastomoses.
Measured: 1 day, from moment of implant until discharge
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 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 vascular access's functionality Functional patency: defined as an AV access that can be cannulated with two dialysis needles for at least 75% of dialysis sessions within a 4-week period to achieve the prescribed dialysis.
Measured: 6, 12, 18, 24, and 60 months
Time 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, 60 months
Incidence rate of access site infections
Infections are defined as all device or procedure related infections potentially resulting from surgical manipulations or device cannulation, including both minor and major infections.
Measured: 6, 12, 18, 24, and 60 months
Proportion of hemodialysis sessions completed via a central venous catheter (CVC) during the first 12 months of access creation and access cannulation, irrespective of access abandonment
Measured: 12 months
Time to the first cannulation
Assessed only in subjects already on dialysis at the time of implant
Measured: 12 months
Following the first cannulation, the number of days with CVC in situ (catheter contact time) during the first 12 months, irrespective of access abandonment
Measured: 12 months
Rate of peri-reintervention vascular injuries
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start11 Nov 2024
- Primary completionJan 2028 (estimated)
- Study completionJan 2032 (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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xeltis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494631
- Sponsor's protocol ID
- XEL-CR-12
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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
- Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft
- ClinicalTrials.gov ID
- NCT06494631
- Acronym / sponsor ID
- XEL-CR-12
- Conditions
- End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- XeltisIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 10 Jul 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 multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min, who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating 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 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 (within the first 6 months of follow-up) or maintain hemodialysis therapy and are deemed unsuitable for fistula creation by the investigational surgeon.
- At least 18 years of age at screening.
- Suitable anatomy (e.g. a target vein with a minimum diameter of 4mm) 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.
Key exclusion criteria (17 listed)
- History or evidence of severe cardiac disease (NYHA Functional Class IV and/or EF <25%), myocardial infarction within 6 months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina.
- Uncontrolled or poorly controlled diabetes in the opinion of the investigator. Recommended standards of A1c level <8% / 183 mg/dl / 10.2 eAG.
- Abnormal blood values (e.g., leukopenia with white blood cell count (WBC) <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.
- 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, restorative 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
Secondary patency rate in survivors
Time frame: 12 months
Secondary patency is defined as the interval between vascular access creation and abandonment with or without interventions (operative or endovascular) aimed to maintain or restore the vascular access's functionality. Patients who died or changed dialysis modality before 12 months will be excluded from the primary effectiveness analysis if loss of secondary patency was not observed before these events
Rate of device related infections and bleeding
Time frame: 12 months
Infections are defined as: All device or procedure related infections potentially resulting from surgical manipulations or device cannulation, including both minor and major infections., Bleeding (procedure or device related bleeding, at least BARC 2) and device related hematoma defined as blood accumulation around the graft arising from the implantation or cannulation that triggered a medical or surgical action
10 secondary outcomes
Freedom from device-related SAE
Time frame: Discharge, 1, 3, 6, 12, 18, 24, and 60 months
Implantation success rate
Time frame: 1 day, from moment of implant until discharge
Patency (primary, primary assisted, secondary, and functional) rates
Time frame: 6, 12, 18, 24, and 60 months
Time 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, 60 months
Incidence rate of access site infections
Time frame: 6, 12, 18, 24, and 60 months
Proportion of hemodialysis sessions completed via a 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 the first cannulation
Time frame: 12 months
Following the first cannulation, the number of days with CVC in situ (catheter contact time) during the first 12 months, irrespective of access abandonment
Time frame: 12 months
Rate of peri-reintervention vascular injuries
Time frame: 6 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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: 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 7 sites in United States.
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: enrolling by invitation, 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 7 sites in United States. 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?
Secondary patency rate in survivors (time frame: 12 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.