Xeltis Hemodialysis Access Graft: aXess Pivotal Study

NCT ID: NCT05473299

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-04
• Study Completion Date: 2029-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

aXess graft

Group Type: EXPERIMENTAL

Xeltis Hemodialysis Access (aXess) graft

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

1. Unsuitable anatomy to implant the aXess graft (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xeltis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mauro Gargiulo, Prof

Role: PRINCIPAL_INVESTIGATOR

Policlinico di Sant'Orsola

An de Vriese, Dr

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Jan AV

Locations

AZ Sint Jan Brugge

Bruges, , Belgium

ZOL Genk

Genk, , Belgium

UZ Ghent

Ghent, , Belgium

Universitätsklinikum Köln

Cologne, , Germany

LAIKO General Hospital of Athens

Athens, , Greece

University General Hospital of Patras

Pátrai, , Greece

Ospedali Riuniti Torrette di Ancona

Ancona, , Italy

Policlinico di Bari

Bari, , Italy

Policlinico di Sant'Orsola

Bologna, , Italy

Università degli studi di Padova / Azienda ospedaliera di Padova

Padua, , Italy

Universita degli studi dell'Insubria

Varese, , Italy

Pauls Stradins Clinical University Hospital

Riga, , Latvia

Private hospital MedPolonia Poznan

Poznan, , Poland

The Lower Silesia Center of Heart Diseases MEDINET

Wroclaw, , Poland

Santa Maria Hospital

Lisbon, , Portugal

Grupo de Estudos Vasculares

Porto, , Portugal

DaVita Sacavém

Sacavém, , Portugal

Bellvitge University Hospital

Barcelona, , Spain

Hospital Clínic de Barcelona

Barcelona, , Spain

Hospital Universitario de la Ribera

Valencia, , Spain

University Hospitals Birmingham - QE

Birmingham, , United Kingdom

Queen Elizabeth University Hospital

Glasgow, , United Kingdom

Countries

Belgium; Germany; Greece; Italy; Latvia; Poland; Portugal; Spain; United Kingdom

Other Identifiers

XEL-CR-10

Identifier Type: -

Identifier Source: org_study_id