Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study

NCT ID: NCT06329310

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-16
• Study Completion Date: 2026-12-31

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

aXess-E conduit

Group Type: EXPERIMENTAL

aXess-E conduit

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

1. Unsuitable anatomy to implant the aXess-E conduit (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xeltis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital de Santa Maria

Lisbon, , Portugal

Site Status: RECRUITING

Kliničko bolnički centar Zvezdara Klinika za Interne Bolesti

Belgrade, , Serbia

Site Status: RECRUITING

Countries

Portugal; Serbia

Central Contacts

Eliane Schutte

Role: CONTACT

clinical@xeltis.com

+31 40 751 7614

Facility Contacts

Augusto Ministro

Role: primary

Marijana Bogosavac

Role: primary

Other Identifiers

XEL-CR-14

Identifier Type: -

Identifier Source: org_study_id