Xeltis Hemodialysis Access Graft: aXess Pivotal Study

Not Applicable

Active, not recruiting

• Conditions: End-stage Renal Disease
• Interventions: Device: Xeltis Hemodialysis Access (aXess) graft

• Registration Number: NCT05473299
• Lead Sponsor: Xeltis

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-25
• Study Start: 2022-11-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-06-30
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
aXess graft	Xeltis Hemodialysis Access (aXess) graft	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time (expressed in months) to first intervention and to access abandonment	60 months
Implantation success rate	1 day, from moment of implant until end of procedure day	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.
Rate of access-related interventions required to achieve/maintain patency	6, 12, 18, 24, and 60 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
Freedom from device-related SAE	12, 18, 24, and 60 months
Rate of access site infections	6, 12, 18, 24, and 60 months
Patency (primary, primary assisted, secondary, and functional) rates	6, 12, 18, 24 and 60 months	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).
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

Trial Locations

Locations (22)

LAIKO General Hospital of Athens; 🇬🇷 Athens, Greece

Private hospital MedPolonia Poznan; 🇵🇱 Poznań, Poland

University Hospitals Birmingham - QE; 🇬🇧 Birmingham, United Kingdom

AZ Sint Jan Brugge; 🇧🇪 Brugge, Belgium

ZOL Genk; 🇧🇪 Genk, Belgium

UZ Ghent; 🇧🇪 Ghent, Belgium

Universitätsklinikum Köln; 🇩🇪 Köln, Germany

University General Hospital of Patras; 🇬🇷 Patras, 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; 🇮🇹 Padova, Italy

Universita degli studi dell'Insubria; 🇮🇹 Varese, Italy

Pauls Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia

The Lower Silesia Center of Heart Diseases MEDINET; 🇵🇱 Wrocław, Poland

Santa Maria Hospital; 🇵🇹 Lisboa, 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

Queen Elizabeth University Hospital; 🇬🇧 Glasgow, United Kingdom