Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study
ConditionEnd Stage Renal Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXeltis
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
aXess-E conduit
DeviceThe 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: aXess-E conduitExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Patency rate
Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.
Time frame
6 months2
Freedom from device-related Serious Adverse Event (SAE)
Time frame
6 monthsSecondary outcomes
1
Implantation success rate
Defined as a technically successful aXess-E conduit implantation in the planned configuration, free from kinking and tension in the anastomoses.
Time frame
1 day, from moment of implant until end of procedure day2
Primary patency rate
Primary patency: Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.
Time frame
6, 12, 18, and 24 months3
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.
Time frame
6, 12, 18, and 24 months4
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).
Time frame
6, 12, 18, and 24 months Source ClinicalTrials.gov