Prospective, Non-randomized Pivotal Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft: aXess Pivotal Study

Xeltis22 sites in 9 countries120 target enrollmentNovember 4, 2022

ConditionsEnd-stage Renal Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: End-stage Renal Disease
Sponsor: Xeltis
Enrollment: 120
Locations: 22
Primary Endpoint: Freedom from device-related SAE during the first 6 months
Status: Active, not recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 4, 2022

End Date

December 31, 2029

Last Updated

9 months ago

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 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

Exclusion Criteria

•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

Outcomes

Primary Outcomes

Freedom from device-related SAE during the first 6 months

Time Frame: up to 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

Implantation success rate(1 day, from moment of implant until end of procedure day)
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)
Time (expressed in months) to first intervention and to access abandonment(60 months)
Patency (primary, primary assisted, secondary, and functional) rates(6, 12, 18, 24 and 60 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(12 months)
Time to first cannulation(12 months)