Xeltis Hemodialysis Access Graft: aXess Pivotal Study

NCT05473299 | Active Not Recruiting DMC

• 1 other identifier: XEL-CR-10
• Study Type: interventional
• Target: 120
• Locations: 9 countries
• Sites: 22

Brief Summary

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.

Conditions

End-stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Implantation success rate

  1 day, from moment of implant until end of procedure day

• Patency (primary, primary assisted, secondary, and functional) rates

  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

Study Arms (1)

aXess graft

EXPERIMENTAL

Device: Xeltis Hemodialysis Access (aXess) graft

Interventions

Xeltis Hemodialysis Access (aXess) graft DEVICE

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.

aXess graft

Eligibility Criteria

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

You may qualify if:

• Subjects with end-stage renal disease (ESRD) who require placement of an AVG in the upper extremity to start or maintain hemodialysis therapy
• At least 18 years of age at screening
• Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an aXess graft
• The patient, or legal representative, 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 six months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
• Uncontrolled or poorly controlled diabetes
• Abnormal blood values 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 previous failed graft
• Previous enrolment in this study
• Subject is participating in another study
• Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
• Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit

Sponsors & Collaborators

• Xeltis: lead

Study Sites (22)

AZ Sint Jan Brugge

Bruges, Belgium

Location

ZOL Genk

Genk, Belgium

Location

UZ Ghent

Ghent, Belgium

Location

Universitätsklinikum Köln

Cologne, Germany

Location

LAIKO General Hospital of Athens

Athens, Greece

Location

University General Hospital of Patras

Pátrai, Greece

Location

Ospedali Riuniti Torrette di Ancona

Ancona, Italy

Location

Policlinico di Bari

Bari, Italy

Location

Policlinico di Sant'Orsola

Bologna, Italy

Location

Università degli studi di Padova / Azienda ospedaliera di Padova

Padua, Italy

Location

Universita degli studi dell'Insubria

Varese, Italy

Location

Pauls Stradins Clinical University Hospital

Riga, Latvia

Location

Private hospital MedPolonia Poznan

Poznan, Poland

Location

The Lower Silesia Center of Heart Diseases MEDINET

Wroclaw, Poland

Location

Santa Maria Hospital

Lisbon, Portugal

Location

Grupo de Estudos Vasculares

Porto, Portugal

Location

DaVita Sacavém

Sacavém, Portugal

Location

Bellvitge University Hospital

Barcelona, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Hospital Universitario de la Ribera

Valencia, Spain

Location

University Hospitals Birmingham - QE

Birmingham, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Transplantation

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

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Mauro Gargiulo, Prof

  Policlinico di Sant'Orsola

  PRINCIPAL INVESTIGATOR

• An de Vriese, Dr

  AZ Sint-Jan AV

  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: July 6, 2022
• First Posted: July 25, 2022
• Study Start: November 4, 2022
• Primary Completion: June 23, 2025
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (3); BE (3); GR (2); LA (1); GB (2); DE (1); PL (2); IT (5); ES (3)