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

NCT06329310 | Recruiting DMC

• 1 other identifier: XEL-CR-14
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• Primary Patency rate

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

  6 months

• Freedom from device-related Serious Adverse Event (SAE)

  6 months

Secondary Outcomes (12)

• Implantation success rate

  1 day, from moment of implant until end of procedure day

• Primary patency rate

  6, 12, 18, and 24 months

• Primary assisted patency rate

  6, 12, 18, and 24 months

• Secondary patency rate

  6, 12, 18, and 24 months

• Functional patency rate

  6, 12, 18, and 24 months

Study Arms (1)

aXess-E conduit

EXPERIMENTAL

Device: aXess-E conduit

Interventions

aXess-E conduit DEVICE

The aXess-E conduit is a sterile, regenerative biodegradable polymer-based vascular conduit, 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-E conduit is able to support both straight and loop configurations and may be implanted in the upper arm and forearm.

aXess-E conduit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Previous dialysis access conduit in the operative limb unless the aXess-E conduit can be placed more proximally than the previous failed conduit
• Previous enrolment in this study
• Subject is participating in another study
• Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
• Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit

Sponsors & Collaborators

• Xeltis: lead

Study Sites (2)

Hospital de Santa Maria

Lisbon, Portugal

RECRUITING

Kliničko bolnički centar Zvezdara Klinika za Interne Bolesti

Belgrade, Serbia

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eliane Schutte

CONTACT

+31 40 751 7614; clinical@xeltis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: December 16, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1); SE (1)