Clinical trial NCT06329310: Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study
Official title: Prospective, Non-randomized Feasibility Study to Confirm the Safety and Performance of the Xeltis Hemodialysis Access Conduit: aXess-E Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Renal Disease
Lead sponsor: Xeltis
Sponsor class: INDUSTRY
First posted: 2024-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Primary Patency rate
timeFrame: 6 months
measure: Freedom from device-related Serious Adverse Event (SAE)
timeFrame: 6 months
Secondary outcomes:
measure: Implantation success rate
timeFrame: 1 day, from moment of implant until end of procedure day
measure: Primary patency rate
timeFrame: 6, 12, 18, and 24 months
measure: Primary assisted patency rate
timeFrame: 6, 12, 18, and 24 months
measure: Secondary patency rate
timeFrame: 6, 12, 18, and 24 months
measure: Functional patency rate
timeFrame: 6, 12, 18, and 24 months
measure: Time (expressed in months) to first intervention and to access abandonment
timeFrame: 24 months
measure: Rate of access-related interventions required to achieve/maintain patency
timeFrame: 6, 12, 18, and 24 months
measure: Freedom from device-related SAE
timeFrame: 12, 18, and 24 months
measure: Rate of access site infections
timeFrame: 6, 12, 18, and 24 months
measure: 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
timeFrame: 24 months
measure: Time to first cannulation
timeFrame: 24 months
measure: Following first cannulation, number of days with CVC in situ (catheter contact time) irrespective of access abandonment
timeFrame: 12 months
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Hospital de Santa Maria
city: Belgrade
country: Serbia
facility: Kliničko bolnički centar Zvezdara Klinika za Interne Bolesti
Study officials:
References: