Xeltis Hemodialysis Access Graft (aXess) US Study (NCT06494631) | Clinical Trial Compass
By InvitationNot Applicable
Xeltis Hemodialysis Access Graft (aXess) US Study
United States140 participantsStarted 2024-11-11
Plain-language summary
A multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min, who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating surgeon.
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 AVG in the upper extremity to start (within the first 6 months of follow-up) or maintain hemodialysis therapy and are deemed unsuitable for fistula creation by the investigational surgeon.
. At least 18 years of age at screening.
. Suitable anatomy (e.g. a target vein with a minimum diameter of 4mm) for the implantation of an aXess graft
. The patient 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
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.
. History or evidence of severe cardiac disease (NYHA Functional Class IV and/or EF \<25%), myocardial infarction within 6 months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina.
. Uncontrolled or poorly controlled diabetes in the opinion of the investigator. Recommended standards of A1c level \<8% / 183 mg/dl / 10.2 eAG.
. Abnormal blood values (e.g., leukopenia with white blood cell count (WBC) \<4,000/mm³ and/or anemia with Hemoglobin \<8g/dL and/or thrombocytopenia \<100,000/mm³) 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.