Xeltis Hemodialysis Access Graft (aXess) US Study

Official title

Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft

Overview

A multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min, who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating surgeon.

Interventions

• Device Xeltis Hemodialysis Access (aXess) graft
  The aXess graft is a sterile, restorative 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.

Primary outcome measures

• Secondary patency rate in survivors [Time frame: 12 months]
• Rate of device related infections and bleeding [Time frame: 12 months]

Secondary outcome measures (10)

• Freedom from device-related SAE [Time frame: Discharge, 1, 3, 6, 12, 18, 24, and 60 months]
• Implantation success rate [Time frame: 1 day, from moment of implant until discharge]
• Patency (primary, primary assisted, secondary, and functional) rates [Time frame: 6, 12, 18, 24, and 60 months]
• Time to first intervention and to access abandonment [Time frame: 60 months]
• Rate of access-related interventions required to achieve/maintain patency [Time frame: 6, 12, 18, 24, 60 months]
• Incidence rate of access site infections [Time frame: 6, 12, 18, 24, and 60 months]
• Proportion of hemodialysis sessions completed via a central venous catheter (CVC) during the first 12 months of access creation and access cannulation, irrespective of access abandonment [Time frame: 12 months]
• Time to the first cannulation [Time frame: 12 months]
• Following the first cannulation, the number of days with CVC in situ (catheter contact time) during the first 12 months, irrespective of access abandonment [Time frame: 12 months]
• Rate of peri-reintervention vascular injuries [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

• Subjects with end-stage renal disease (ESRD) who require placement of an AVG in the upper extremity to start (within the first 6 months of follow-up) or maintain hemodialysis therapy and are deemed unsuitable for fistula creation by the investigational surgeon.
• At least 18 years of age at screening.
• Suitable anatomy (e.g. a target vein with a minimum diameter of 4mm) 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 (NYHA Functional Class IV and/or EF <25%), myocardial infarction within 6 months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina.
• Uncontrolled or poorly controlled diabetes in the opinion of the investigator. Recommended standards of A1c level <8% / 183 mg/dl / 10.2 eAG.
• Abnormal blood values (e.g., leukopenia with white blood cell count (WBC) <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.
• 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 previously failed graft.
• Previous enrollment in this study.
• Subject is participating in another study.
• A female who is breastfeeding or of childbearing potential with a positive pregnancy test or not using adequate contraception.
• Any other condition which, in the judgment 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 not suitable; severe calcification).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 7 centers

• AKDHC Medical Research Services, LLC — Phoenix
• AKDHC Medical Research Services, LLC — Tuscon
• Sarasota Memorial Hospital — Sarasota
• Brigham and Women's Hospital — Boston
• Greenwood Leflore Hospital — Greenwood
• Surgical Specialists of Charlotte — Charlotte
• Flow Vascular, Surgery Specialty Hospitals of America — Pasadena

Identifiers

NCT: NCT06494631 · XEL-CR-12

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗