Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study
Portugal, Serbia20 participantsStarted 2024-12-16
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Patency rate
Timeframe: 6 months
2
Freedom from device-related Serious Adverse Event (SAE)
. 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