Prospective, Non-randomized Feasibility Study to Confirm the Safety and Performance of the Xeltis Hemodialysis Access Conduit: aXess-E Study

Xeltis2 sites in 2 countries20 target enrollmentDecember 16, 2024

ConditionsEnd Stage Renal Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: End Stage Renal Disease
Sponsor: Xeltis
Enrollment: 20
Locations: 2
Primary Endpoint: Freedom from device-related Serious Adverse Event (SAE)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, 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.

Registry

clinicaltrials.gov

Start Date

December 16, 2024

End Date

December 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Xeltis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects with end-stage renal disease (ESRD) who require placement of an Arteriovenous Graft (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-E conduit
•The patient has been informed about the nature of the study, understands and agrees to its provisions, and has personally 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 (New York Heart Association (NYHA) Functional Class IV and/or Ejection Fraction (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/ conduit 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 conduit implantation

Outcomes

Primary Outcomes

Freedom from device-related Serious Adverse Event (SAE)

Time Frame: 6 months

Primary Patency rate

Time Frame: 6 months

Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.

Secondary Outcomes

Following first cannulation, number of days with CVC in situ (catheter contact time) irrespective of access abandonment(12 months)
Time to first cannulation(24 months)
Functional patency rate(6, 12, 18, and 24 months)
Time (expressed in months) to first intervention and to access abandonment(24 months)
Rate of access site infections(6, 12, 18, and 24 months)
Implantation success rate(1 day, from moment of implant until end of procedure day)
Primary patency rate(6, 12, 18, and 24 months)
Secondary patency rate(6, 12, 18, and 24 months)
Freedom from device-related SAE(12, 18, and 24 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(24 months)
Primary assisted patency rate(6, 12, 18, and 24 months)
Rate of access-related interventions required to achieve/maintain patency(6, 12, 18, and 24 months)