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RECRUITINGNA

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

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

NCT06329310•Xeltis

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

Locations (2)

Hospital de Santa Maria

Lisbon, Portugal

Kliničko bolnički centar Zvezdara Klinika za Interne Bolesti

Belgrade, Serbia

Key Dates

Start Date

December 16, 2024

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2026

Last Updated

April 4, 2025

Enrollment

ESTIMATED participants

Conditions

End Stage Renal Disease

Interventions

aXess-E conduit

DEVICE

Contacts

Eliane Schutte

CONTACT

+31 40 751 7614 clinical@xeltis.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

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