Xeltis Hemodialysis Access Conduit: aXess-E Study

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Device: aXess-E conduit

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eliane Schutte; Phone Number: +31 40 751 7614; Email: clinical@xeltis.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: aXess-E conduit

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency rate	Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.	6 months
Freedom from device-related SAE		6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 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
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
Time (expressed in months) to first intervention and to access abandonment		24 months
Rate of access-related interventions required to achieve/maintain patency		6, 12, 18, and 24 months
Freedom from device-related SAE		12, 18, and 24 months
Rate of access site infections		6, 12, 18, and 24 months
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
Time to first cannulation	Assessed only in subjects who are already on dialysis at the time of implant.	24 months
Following first cannulation, number of days with CVC in situ (catheter contact time) irrespective of access abandonment		12 months

Collaborators and Investigators

• Sponsor: Xeltis

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: XEL-CR-14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No