Actively Recruiting
Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study
Led by Xeltis · Updated on 2025-04-04
20
Participants Needed
2
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with end-stage renal disease requiring an arteriovenous graft in the upper extremity for hemodialysis
- Suitable vein anatomy with a minimum diameter of 5mm for conduit implantation
- Provided written informed consent after understanding the study
- Agree to pre- and post-procedure follow-up
- Life expectancy of at least 12 months
You will not qualify if you...
- Severe cardiac disease including NYHA Class IV, ejection fraction less than 25%, recent myocardial infarction within 6 months, ventricular tachyarrhythmias requiring treatment, or unstable angina
- Uncontrolled or poorly controlled diabetes
- Abnormal blood values affecting recovery or conduit hemostasis
- Reduced liver function with bilirubin over twice normal, INR over 1.5, or prothrombin time over 18 seconds
- Active local or systemic infection
- Known heparin-induced thrombocytopenia
- Active bleeding disorder, coagulopathy, or thromboembolic disease
- Allergies to nitinol or medications like contrast agents or aspirin that cannot be medically managed
- Anticipated kidney transplant within 6 months
- Known or suspected central vein obstruction on the planned implantation side
- Previous dialysis access conduit in operative limb unless aXess-E can be placed more proximally
- Prior participation in this study
- Participation in another clinical study
- Pregnant or breastfeeding women or women not using adequate contraception
- Any condition that would interfere with safety and performance evaluation
- During surgery, unsuitable anatomy such as smaller than expected target vein or artery diameter or severe calcification
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hospital de Santa Maria
Lisbon, Portugal
Actively Recruiting
2
Kliničko bolnički centar Zvezdara Klinika za Interne Bolesti
Belgrade, Serbia
Actively Recruiting
Research Team
E
Eliane Schutte
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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