Xeltis Hemodialysis Access Graft (aXess) US Study

NCT06494631 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: XEL-CR-12
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 7

Brief Summary

A multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min, who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating surgeon.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• Secondary patency rate in survivors

  Secondary patency is defined as the interval between vascular access creation and abandonment with or without interventions (operative or endovascular) aimed to maintain or restore the vascular access's functionality. Patients who died or changed dialysis modality before 12 months will be excluded from the primary effectiveness analysis if loss of secondary patency was not observed before these events

  12 months

• Rate of device related infections and bleeding

  Infections are defined as: All device or procedure related infections potentially resulting from surgical manipulations or device cannulation, including both minor and major infections., Bleeding (procedure or device related bleeding, at least BARC 2) and device related hematoma defined as blood accumulation around the graft arising from the implantation or cannulation that triggered a medical or surgical action

  12 months

Secondary Outcomes (10)

• Freedom from device-related SAE

  Discharge, 1, 3, 6, 12, 18, 24, and 60 months

• Implantation success rate

  1 day, from moment of implant until discharge

• Patency (primary, primary assisted, secondary, and functional) rates

  6, 12, 18, 24, and 60 months

• Time to first intervention and to access abandonment

  60 months

• Rate of access-related interventions required to achieve/maintain patency

  6, 12, 18, 24, 60 months

Study Arms (1)

aXess graft

EXPERIMENTAL

Device: Xeltis Hemodialysis Access (aXess) graft

Interventions

Xeltis Hemodialysis Access (aXess) graft DEVICE

The aXess graft is a sterile, restorative biodegradable polymer-based vascular graft, 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 graft is able to support both straight and loop configurations and may be implanted in the upper arm and forearm.

aXess graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with end-stage renal disease (ESRD) who require placement of an AVG in the upper extremity to start (within the first 6 months of follow-up) or maintain hemodialysis therapy and are deemed unsuitable for fistula creation by the investigational surgeon.
• At least 18 years of age at screening.
• Suitable anatomy (e.g. a target vein with a minimum diameter of 4mm) for the implantation of an aXess graft
• The patient has been informed about the nature of the study, agrees to its provisions, and has provided written informed consent.
• The patient has been informed and agrees to pre- and post-procedure follow-up.
• Life expectancy of at least 12 months.

You may not qualify if:

• History or evidence of severe cardiac disease (NYHA Functional Class IV and/or EF \<25%), myocardial infarction within 6 months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina.
• Uncontrolled or poorly controlled diabetes in the opinion of the investigator. Recommended standards of A1c level \<8% / 183 mg/dl / 10.2 eAG.
• Abnormal blood values (e.g., leukopenia with white blood cell count (WBC) \<4,000/mm³ and/or anemia with Hemoglobin \<8g/dL and/or thrombocytopenia \<100,000/mm³) that could influence patient recovery and or/ graft hemostasis.
• 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.
• Any active local or systemic infection.
• Known heparin-induced thrombocytopenia.
• Known active bleeding disorder and/or any coagulopathy or thromboembolic disease.
• Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically.
• Anticipated renal transplant within 6 months.
• Known or suspected central vein obstruction on the side of planned graft implantation.
• Previous dialysis access graft in the operative limb, unless the aXess graft can be placed more proximally than the previously failed graft.
• Previous enrollment in this study.
• Subject is participating in another study.
• A female who is breastfeeding or of childbearing potential with a positive pregnancy test or not using adequate contraception.
• Any other condition which, in the judgment of the investigator, would preclude adequate evaluation for the safety and performance of the study conduit.

Sponsors & Collaborators

• Xeltis: lead

Study Sites (7)

AKDHC Medical Research Services, LLC

Phoenix, Arizona, 85016, United States

Location

AKDHC Medical Research Services, LLC

Tuscon, Arizona, 85718, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Greenwood Leflore Hospital

Greenwood, Mississippi, 38930, United States

Location

Surgical Specialists of Charlotte

Charlotte, North Carolina, 28210, United States

Location

Flow Vascular, Surgery Specialty Hospitals of America

Pasadena, Texas, 77504, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2032
• Last Updated: September 2, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)