First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft

NCT04898153 | Active Not Recruiting DMC

• 1 other identifier: XEL-CR-08
• Study Type: interventional
• Target: 20
• Locations: 4 countries
• Sites: 6

Brief Summary

A feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.

Conditions

End Stage Renal Disease; End Stage Renal Failure on Dialysis

Outcome Measures

Primary Outcomes (2)

• Freedom from device related serious adverse events

  The number of patients who have a device related serious adverse event

  6 months

• Functional patency of graft

  The number of patients with a functionally patent graft

  6 months

Secondary Outcomes (10)

• Freedom from device related serious adverse events

  12, 18, 24, and 60 months

• Functional patency of graft

  12, 18, 24, and 60 months

• Patency (primary, primary assisted, and secondary) of graft

  6, 12, 18, 24, and 60 months

• Time to potential central venous catheter removal

  Assessed retrospectively at 30 days

• Time to loss of patency (primary, primary assisted, and secondary)

  6, 12, 18, 24, and 60 months

Study Arms (1)

aXess

EXPERIMENTAL

Patients will be implanted with the Xeltis hemodialysis access graft (aXess)

Device: aXess

Interventions

aXess DEVICE

Patients will be implanted with one Xeltis hemodialysis access device (aXess) in the arm

aXess

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects older than 18 years with end-stage renal disease (ESRD) who are not, or who are no longer, candidates for creation of an autogenous AV fistula, and therefore require placement of an AV graft in the upper extremity to start or maintain hemodialysis therapy
• Suitable anatomy 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 (NHYA Functional Class IV and/or EF \<30%), myocardial infarction within six months of study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
• Stroke within six months before study entry
• Active clinically significant autoimmune / inflammatory disease, immunodeficiency (including AIDS / HIV), use of immunosuppressive therapy or medication that likely interferes with restorative therapies
• Abnormal blood values (e.g. leurkopenia with white blood cell (WBC) count \< 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
• Any active local or systemic infection (WBC \> 15,000/mm3)
• Uncontrolled or poorly controlled diabetes (hemoglovin A1c \> 8% despite standard care) or hospitalization for poor glucose control within the previous 6 months
• Reduced liver function, defined as: \>2x the upper limit of normal for serum bilirubin, aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase; International Normalized Ratio (INR) \> 1.5 or prothrombin time (PT) \> 18 seconds
• Known heparin-induced thrombocytopenia
• Active bleeding disorder and/or any coagulopathy or thrombo embolic disease
• History or evidence of severe peripheral vascular disease in the upper limbs
• 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 previous failed graft
• More than 1 failed dialysis access graft in the operative limb
• Anticipated renal transplant within 6 months
• Subjects receiving a forearm graft which crosses the elbow

Sponsors & Collaborators

• Xeltis: lead

Study Sites (6)

A.Z. Sint Jan

Bruges, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

UZ Ghent

Ghent, Belgium

Location

Universita degli studi dell'Insubria

Varese, Italy

Location

P. Stradins Clinical University Hospital

Riga, Latvia

Location

Vilnius University Hospital Santaros Klinikos Corpus A.

Vilnius, Lithuania

Location

Related Publications (1)

• Tozzi M, De Letter J, Krievins D, Jushinskis J, D'Haeninck A, Rucinskas K, Miglinas M, Baltrunas T, Nauwelaers S, Schoen FJ, Virmani R, De Vriese AS, Moll F, Vermassen F. Endogenous tissue restoration in a hemodialysis conduit: Performance and safety after 1-year of follow-up. J Vasc Access. 2025 Nov 21:11297298251395823. doi: 10.1177/11297298251395823. Online ahead of print.

  PMID: 41272425 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frank Vermassen, MD

  UZ Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: May 24, 2021
• Study Start: June 10, 2021
• Primary Completion: March 24, 2023
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

BE (3); LI (1); IT (1); LA (1)