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Active, Not Recruiting

NCT Number: NCT05473299

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Sint Jan Brugge, Bruges, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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:

  • Unsuitable anatomy to implant the aXess graft (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)

Treatment and study plan

Xeltis Hemodialysis Access (aXess) graft

Device

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.

Primary outcomes

  1. Primary patency rate

    Time frame: 6 months

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

  2. Freedom from device-related SAE during the first 6 months

    Time frame: up to 6 months

Secondary outcomes

  1. Implantation success rate

    Time frame: 1 day, from moment of implant until end of procedure day

    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.

  2. Patency (primary, primary assisted, secondary, and functional) rates

    Time frame: 6, 12, 18, 24 and 60 months

    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).

  3. Time (expressed in months) to first intervention and to access abandonment

    Time frame: 60 months

  4. Rate of access-related interventions required to achieve/maintain patency

    Time frame: 6, 12, 18, 24, and 60 months

  5. Freedom from device-related SAE

    Time frame: 12, 18, 24, and 60 months

  6. Rate of access site infections

    Time frame: 6, 12, 18, 24, and 60 months

  7. 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

  8. Time to first cannulation

    Time frame: 12 months

  9. 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

Sponsors and collaborators

Lead sponsor

Xeltis

Industry

Registry information

Official study title

Prospective, Non-randomized Pivotal Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft: aXess Pivotal Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2029
First posted
Jul 25, 2022
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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