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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06329310
Other study ID # XEL-CR-14
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2024
Est. completion date December 2026

Study information

Verified date March 2024
Source Xeltis
Contact Eliane Schutte
Phone +31 40 751 7614
Email clinical@xeltis.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date December 2026
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subjects with end-stage renal disease (ESRD) who require placement of an 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 (NYHA Functional Class IV and/or 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
aXess-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

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Xeltis

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Patency rate Defined as the interval between vascular access creation and the first intervention to maintain or restore patency. 6 months
Primary Freedom from device-related SAE 6 months
Secondary Implantation success rate Defined as a technically successful aXess-E conduit implantation in the planned configuration, free from kinking and tension in the anastomoses. 1 day, from moment of implant until end of procedure day
Secondary Primary patency rate Primary patency: Defined as the interval between vascular access creation and the first intervention to maintain or restore patency. 6, 12, 18, and 24 months
Secondary Primary assisted patency rate Assisted primary patency: Defined as the interval between vascular access creation and the first occlusion (thrombosis), including interventions (operative or endovascular) aimed to maintain the functionality the vascular access. 6, 12, 18, and 24 months
Secondary Secondary patency rate Secondary patency: Defined as the interval between vascular access creation and abandonment with or without interventions (operative or endovascular) aimed to maintain the functionality the vascular access, including occurrence of a censored event (death, change of modality, loss of follow-up). 6, 12, 18, and 24 months
Secondary Functional patency rate Functional patency: Defined as the interval between first cannulation and abandonment, including occurrence of a censored event (death, change of modality, loss of follow-up). 6, 12, 18, and 24 months
Secondary Time (expressed in months) to first intervention and to access abandonment 24 months
Secondary Rate of access-related interventions required to achieve/maintain patency 6, 12, 18, and 24 months
Secondary Freedom from device-related SAE 12, 18, and 24 months
Secondary Rate of access site infections 6, 12, 18, and 24 months
Secondary 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 24 months
Secondary Time to first cannulation Assessed only in subjects who are already on dialysis at the time of implant. 24 months
Secondary Following first cannulation, number of days with CVC in situ (catheter contact time) irrespective of access abandonment 12 months
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