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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: End Stage Renal Disease; End Stage Renal Failure on Dialysis
• Intervention / Treatment: Device: aXess

Detailed Description

A prospective, single arm, non-randomized FIH feasibility study to evaluate the preliminary safety and performance of the Xeltis hemodialysis access graft 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, and are deemed not suitable for fistula creation by the operating surgeon.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium
    • A.Z. Sint Jan
  • Genk, Belgium
    • Ziekenhuis Oost-Limburg
  • Ghent, Belgium
    • UZ Ghent
• Italy
  • Varese, Italy
    • Università degli Studi dell'Insubria
• Latvia
  • Riga, Latvia
    • P. Stradins Clinical University Hospital
• Lithuania
  • Vilnius, Lithuania
    • Vilnius University Hospital Santaros Klinikos Corpus A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Allergies to study device (Nitinol) or agents/medication, such as contrast agents, aspirin, or clopidogrel, that cant be controlled medically
• Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
• Subject is participating in another study
• Previous enrollment in this study
• Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and efficacy of the study conduit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aXess; Patients will be implanted with the Xeltis hemodialysis access graft (aXess)	Device: aXess; Patients will be implanted with one Xeltis hemodialysis access device (aXess) in the arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from device related serious adverse events	The number of patients who have a device related serious adverse event	12, 18, 24, and 60 months
Functional patency of graft	The number of patients with a functionally patent graft	12, 18, 24, and 60 months
Patency (primary, primary assisted, and secondary) of graft	The number of patients with a patient graft	6, 12, 18, 24, and 60 months
Time to potential central venous catheter removal	Time that patients with a central venous catheter could have had the catheter removed after the Xeltis hemodialysis access graft was placed	Assessed retrospectively at 30 days
Time to loss of patency (primary, primary assisted, and secondary)	Number of days from implant to graft occlusion in patients who no longer have a patent graft	6, 12, 18, 24, and 60 months
Rate of access related interventions required to achieve/maintain patency	Number of interventions that were performed on grafts to achieve/maintain patency	6, 12, and 24 months
Rate of access site infections	Number of access graft sites that become infected	6, 12, and 24 months
Proportion of hemodialysis (HD) sessions completed via central venous catheter	Number of hemodialysis sessions performed with a central venous catheter vs. the number of sessions performed with the Xeltis hemodialysis access graft	12 months
Number of days with central venous catheter in place (catheter contact time)	Number of days the patients have a central venous catheter in place irrespective of access abandonment	12 months
Pseudoaneurysm formation	Number of grafts that have a pseudoaneurysm form	6, 12, and 24 months

Collaborators and Investigators

• Sponsor: Xeltis
• Investigators: Principal Investigator: Frank Vermassen, MD, UZ Ghent

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Actual): March 24, 2023
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: XEL-CR-08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No