Xeltis Hemodialysis Access Graft (aXess) US Study

Enrolling by invitation · Not applicable

Conditions studied: End Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT06494631

Run by

Xeltis

People needed

140

Starts

2024-11-11

Expected to finish

2032-01-01

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Anticipated renal transplant within 6 months.
• Known or suspected central vein obstruction on the side of planned graft implantation.
• Previous dialysis access graft in the operative limb, unless the aXess graft can be placed more proximally than the previously failed graft.
• Previous enrollment in this study.
• Subject is participating in another study.
• A female who is breastfeeding or of childbearing potential with a positive pregnancy test or not using adequate contraception.
• Any other condition which, in the judgment of the investigator, would preclude adequate evaluation for the safety and performance of the study conduit.
• Intra-operative exclusion criteria:
• Unsuitable anatomy to implant the aXess graft (e.g., target vein and/or artery diameter not suitable; severe calcification).

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Greenwood Leflore Hospital — Greenwood, Mississippi, United States
• Surgical Specialists of Charlotte — Charlotte, North Carolina, United States
• Flow Vascular, Surgery Specialty Hospitals of America — Pasadena, Texas, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• AKDHC Medical Research Services, LLC — Phoenix, Arizona, United States
• AKDHC Medical Research Services, LLC — Tuscon, Arizona, United States

Full record on ClinicalTrials.gov

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