RecruitingNot ApplicableNCT06329310

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


Sponsor

Xeltis

Enrollment

20 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of hemodialysis access conduit called aXess-E, made from a specially engineered bioabsorbable material. People with kidney failure who need hemodialysis require a reliable access point in the arm (called an arteriovenous graft or AVG) to connect to the dialysis machine. The aXess-E conduit is designed to last longer and work better than standard synthetic grafts by promoting natural tissue growth around it. **You may be eligible if...** - You have end-stage kidney disease and need hemodialysis - You need a new arteriovenous graft placed in your upper arm - You are 18 or older - You have suitable vein anatomy (target vein at least 5 mm in diameter) - You have a life expectancy of at least 12 months **You may NOT be eligible if...** - You have severe heart failure (NYHA Class IV or ejection fraction below 25%) - You have had a recent heart attack or major cardiovascular event - You have active infections or bleeding problems - You are pregnant - You have had prior failed grafts in the target arm Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEaXess-E conduit

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.


Locations(2)

Hospital de Santa Maria

Lisbon, Portugal

Kliničko bolnički centar Zvezdara Klinika za Interne Bolesti

Belgrade, Serbia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06329310


Related Trials