Xeltis Hemodialysis Access conduit for patients with end-stage renal disease

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

This study is testing a new device called the Xeltis Hemodialysis Access conduit to see if it can safely help adults with end-stage kidney disease get better access for their hemodialysis treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xeltis (industry)
• Locations: 2 sites (Lisbon and 1 other locations)
• Trial ID: NCT06329310 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and performance of the Xeltis Hemodialysis Access conduit, known as aXess-E, in adults with end-stage renal disease who require an Arteriovenous Graft for hemodialysis. It is a prospective, single-arm, non-randomized feasibility study that aims to confirm the conduit’s effectiveness in facilitating hemodialysis access. Participants will be monitored for at least six months following the placement of the conduit to assess its performance and safety.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with end-stage renal disease requiring an Arteriovenous Graft for hemodialysis.

Not a fit: Patients with severe cardiac disease, uncontrolled diabetes, or significant blood abnormalities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective method for hemodialysis access in patients with end-stage renal disease.

How similar studies have performed: While this approach is innovative, it is not clear if similar studies have shown success, as this specific conduit has not been widely tested in prior research.

Eligibility criteria

Inclusion Criteria:

1. 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
2. At least 18 years of age at screening
3. Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an aXess-E conduit
4. The patient has been informed about the nature of the study, understands and agrees to its provisions, and has personally provided written informed consent
5. The patient has been informed and agrees to pre- and post- procedure follow-up
6. Life expectancy of at least 12 months

Exclusion Criteria:

1. 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
2. Uncontrolled or poorly controlled diabetes
3. Abnormal blood values that could influence patient recovery and or/ conduit hemostasis
4. 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
5. Any active local or systemic infection
6. Known heparin-induced thrombocytopenia
7. Known active bleeding disorder and/or any coagulopathy or thromboembolic disease
8. Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically
9. Anticipated renal transplant within 6 months
10. Known or suspected central vein obstruction on the side of planned conduit implantation
11. Previous dialysis access conduit in the operative limb unless the aXess-E conduit can be placed more proximally than the previous failed conduit
12. Previous enrolment in this study
13. Subject is participating in another study
14. Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
15. 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)

Where this trial is running

Lisbon and 1 other locations

• Hospital de Santa Maria — Lisbon, Portugal (RECRUITING)
• Kliničko bolnički centar Zvezdara Klinika za Interne Bolesti — Belgrade, Serbia (RECRUITING)

Study contacts

• Study coordinator: Eliane Schutte

Conditions: End Stage Renal Disease