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NCT Number: NCT06329310

Xeltis Hemodialysis Access (aXess) 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.

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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

Hospital de Santa Maria, Lisbon, Portugal

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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 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

Exclusion criteria

  • 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
  • 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:

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

Treatment and study plan

aXess-E conduit

Device

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.

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 Serious Adverse Event (SAE)

    Time frame: 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-E conduit implantation in the planned configuration, free from kinking and tension in the anastomoses.

  2. Primary patency rate

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

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

  3. Primary assisted patency rate

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

    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.

  4. Secondary patency rate

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

    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).

  5. Functional patency rate

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

    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).

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

    Time frame: 24 months

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

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

  8. Freedom from device-related SAE

    Time frame: 12, 18, and 24 months

  9. Rate of access site infections

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

  10. 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

  11. Time to first cannulation

    Time frame: 24 months

    Assessed only in subjects who are already on dialysis at the time of implant.

  12. Following first cannulation, number of days with CVC in situ (catheter contact time) irrespective of access abandonment

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Eliane Schutte

CONTACT

[email protected]

+31 40 751 7614

Sponsors and collaborators

Lead sponsor

Xeltis

Industry

Registry information

Official study title

Prospective, Non-randomized Feasibility Study to Confirm the Safety and Performance of the Xeltis Hemodialysis Access Conduit: aXess-E Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 25, 2024
Registry last updated
Apr 4, 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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