Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study

Not Applicable

Recruiting

• Conditions: End Stage Renal Disease
• Interventions: Device: aXess-E conduit

• Registration Number: NCT06329310
• Lead Sponsor: Xeltis

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-22
• Study First Posted: 2024-03-25
• Study Start: 2024-12-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. 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
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-E conduit
4. The patient has been informed about the nature of the study, understands and agrees to its provisions, and has personally 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 (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
2. Uncontrolled or poorly controlled diabetes
3. Abnormal blood values that could influence patient recovery and or/ conduit 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 conduit implantation
11. Previous dialysis access conduit in the operative limb unless the aXess-E conduit can be placed more proximally than the previous failed conduit
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-E conduit (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-E conduit	aXess-E conduit	-

Primary Outcome Measures

Name	Time	Method
Freedom from device-related Serious Adverse Event (SAE)	6 months
Primary Patency rate	6 months	Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.

Secondary Outcome Measures

Name	Time	Method
Following first cannulation, number of days with CVC in situ (catheter contact time) irrespective of access abandonment	12 months
Functional patency rate	6, 12, 18, and 24 months	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).
Time (expressed in months) to first intervention and to access abandonment	24 months
Time to first cannulation	24 months	Assessed only in subjects who are already on dialysis at the time of implant.
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	Defined as a technically successful aXess-E conduit implantation in the planned configuration, free from kinking and tension in the anastomoses.
Primary patency rate	6, 12, 18, and 24 months	Primary patency: Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.
Secondary patency rate	6, 12, 18, and 24 months	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).
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	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.
Rate of access-related interventions required to achieve/maintain patency	6, 12, 18, and 24 months

Trial Locations

Locations (2)

Hospital de Santa Maria; 🇵🇹 Lisbon, Portugal

Kliničko bolnički centar Zvezdara Klinika za Interne Bolesti; 🇷🇸 Belgrade, Serbia