Xeltis Hemodialysis Access Conduit: aXess-E Study

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06329310
• Other study ID #: XEL-CR-14
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

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