Status:
ENROLLING_BY_INVITATION
Xeltis Hemodialysis Access Graft (aXess) US Study
Lead Sponsor:
Xeltis
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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-stag...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Intra-operative exclusion criteria:
- 1\. Unsuitable anatomy to implant the aXess graft (e.g., target vein and/or artery diameter not suitable; severe calcification).
Key Trial Info
Start Date :
November 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2032
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06494631
Start Date
November 11 2024
End Date
January 1 2032
Last Update
September 2 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
AKDHC Medical Research Services, LLC
Phoenix, Arizona, United States, 85016
2
AKDHC Medical Research Services, LLC
Tuscon, Arizona, United States, 85718
3
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115