Xeltis Hemodialysis Access Graft: aXess Pivotal Study

Prospective, Non-randomized Pivotal Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft: aXess Pivotal Study

A prospective, single arm, non-randomized pivotal study to evaluate the 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.

Study Overview

• Status: Active, not recruiting
• Conditions: End-stage Renal Disease
• Intervention / Treatment: Device: Xeltis Hemodialysis Access (aXess) graft

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium
    • AZ Sint Jan Brugge
  • Genk, Belgium
    • ZOL GENK
  • Ghent, Belgium
    • UZ Ghent
• Germany
  • Köln, Germany
    • Universitatsklinikum Koln
• Greece
  • Athens, Greece
    • Laiko General Hospital of Athens
  • Patras, Greece
    • University General Hospital of Patras
• Italy
  • Ancona, Italy
    • Ospedali Riuniti Torrette di Ancona
  • Bari, Italy
    • Policlinico di Bari
  • Bologna, Italy
    • Policlinico di Sant'Orsola
  • Padova, Italy
    • Università degli studi di Padova / Azienda ospedaliera di Padova
  • Varese, Italy
    • Università degli Studi dell'Insubria
• Latvia
  • Riga, Latvia
    • Pauls Stradins Clinical University Hospital
• Poland
  • Poznań, Poland
    • Private hospital MedPolonia Poznan
  • Wrocław, Poland
    • The Lower Silesia Center of Heart Diseases MEDINET
• Portugal
  • Lisboa, Portugal
    • Santa Maria Hospital
  • Porto, Portugal
    • Grupo de Estudos Vasculares
  • Sacavém, Portugal
    • DaVita Sacavém
• Spain
  • Barcelona, Spain
    • Hospital Clinic de Barcelona
  • Barcelona, Spain
    • Bellvitge University Hospital
  • Valencia, Spain
    • Hospital Universitario de La Ribera
• United Kingdom
  • Birmingham, United Kingdom
    • University Hospitals Birmingham - QE
  • Glasgow, United Kingdom
    • Queen Elizabeth University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects with end-stage renal disease (ESRD) who require placement of an 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 graft
4. The patient, or legal representative, has been informed about the nature of the study, agrees to its provisions, and has 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 (NYHA Functional Class IV and/or 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/ graft 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 graft implantation
11. Previous dialysis access graft in the operative limb unless the aXess graft can be placed more proximally than the previous failed graft
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 graft (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)

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 graft

Device: Xeltis Hemodialysis Access (aXess) graft; The aXess graft is a sterile, regenerative biodegradable polymer-based vascular graft, consisting of a tubular structure with a 6mm inner diameter. It is comprised of a highly porous polymer matrix and an embedded electropolished nitinol reinforcement layer (Strain Relief System). The aXess graft is able to support both straight and loop configurations and may be implanted in the upper arm and forearm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary patency rate	Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.	6 months
Freedom from device-related SAE during the first 6 months		up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implantation success rate	Defined as a technically successful aXess graft implantation in the planned configuration, free from kinking and tension in the anastomoses. This is assessed at the procedure day itself.	1 day, from moment of implant until end of procedure day
Patency (primary, primary assisted, secondary, and functional) rates	Primary patency: Defined as the interval between vascular access creation and the first intervention to maintain or restore patency. Assisted primary patency: Defined as the interval between vascular access creation and the first occlusion (thrombosis), including interventions (operative or endovascular) aimed to maintain the functionality the vascular access. Secondary patency: Defined as the interval between vascular access creation and abandonment with or without interventions (operative or endovascular) aimed to maintain the functionality the vascular access, including occurrence of a censored event (death, change of modality, loss of follow-up). Functional patency: Defined as the interval between first cannulation and abandonment, including occurrence of a censored event (death, change of modality, loss of follow-up).	6, 12, 18, 24 and 60 months
Time (expressed in months) to first intervention and to access abandonment		60 months
Rate of access-related interventions required to achieve/maintain patency		6, 12, 18, 24, and 60 months
Freedom from device-related SAE		12, 18, 24, and 60 months
Rate of access site infections		6, 12, 18, 24, and 60 months
Proportion of hemodialysis sessions completed via central venous catheter (CVC) during the first 12 months of access creation and access cannulation, irrespective of access abandonment		12 months
Time to first cannulation		12 months
Following first cannulation, number of days with CVC in situ (catheter contact time) during the first 12 months, irrespective of access abandonment		12 months

Collaborators and Investigators

• Sponsor: Xeltis
• Investigators: Principal Investigator: Mauro Gargiulo, Prof, Policlinico di Sant'Orsola; Principal Investigator: An de Vriese, Dr, AZ Sint-Jan AV

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2022
• Primary Completion (Actual): June 23, 2025
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: XEL-CR-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No