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Recruiting NCT06329310

Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study

No phase Interventional End Stage Renal Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: aXess-E conduit.
Who it may be relevant to
Registry conditions: End Stage Renal Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal, Serbia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device aXess-E conduit
    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 outcome measures

  • Primary Patency rate [Time frame: 6 months]
  • Freedom from device-related Serious Adverse Event (SAE) [Time frame: 6 months]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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:

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Portugal · 1 center
  • Hospital de Santa Maria — Lisbon
Serbia · 1 center
  • Kliničko bolnički centar Zvezdara Klinika za Interne Bolesti — Belgrade

Identifiers

NCT: NCT06329310 · XEL-CR-14

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗