Clinical trial NCT06494631: Xeltis Hemodialysis Access Graft (aXess) US Study
Official title: Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: End Stage Renal Disease
Lead sponsor: Xeltis
Sponsor class: INDUSTRY
First posted: 2024-07-10
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. At least 18 years of age at screening.
3. Suitable anatomy (e.g. a target vein with a minimum diameter of 4mm) for the implantation of an aXess graft
4. The patient has been informed about the nature of the study, agrees to its provisions, and has 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 6 months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina.
2. Uncontrolled or poorly controlled diabetes in the opinion of the investigator. Recommended standards of A1c level \<8% / 183 mg/dl / 10.2 eAG.
3. 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.
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 graft implantation.
11. Previous dialysis access graft in the operative limb, unless the aXess graft can be placed more proximally than the previously failed graft.
12. Previous enrollment in this study.
13. Subject is participating in another study.
14. A female who is breastfeeding or of childbearing potential with a positive pregnancy test or not using adequate contraception.
15. 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).

Primary outcomes:
measure: Secondary patency rate in survivors
timeFrame: 12 months
measure: Rate of device related infections and bleeding
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from device-related SAE
timeFrame: Discharge, 1, 3, 6, 12, 18, 24, and 60 months
measure: Implantation success rate
timeFrame: 1 day, from moment of implant until discharge
measure: Patency (primary, primary assisted, secondary, and functional) rates
timeFrame: 6, 12, 18, 24, and 60 months
measure: Time to first intervention and to access abandonment
timeFrame: 60 months
measure: Rate of access-related interventions required to achieve/maintain patency
timeFrame: 6, 12, 18, 24, 60 months
measure: Incidence rate of access site infections
timeFrame: 6, 12, 18, 24, and 60 months
measure: Proportion of hemodialysis sessions completed via a central venous catheter (CVC) during the first 12 months of access creation and access cannulation, irrespective of access abandonment
timeFrame: 12 months
measure: Time to the first cannulation
timeFrame: 12 months
measure: Following the first cannulation, the number of days with CVC in situ (catheter contact time) during the first 12 months, irrespective of access abandonment
timeFrame: 12 months
measure: Rate of peri-reintervention vascular injuries
timeFrame: 6 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: AKDHC Medical Research Services, LLC
state: Arizona
city: Tucson
country: United States
facility: AKDHC Medical Research Services, LLC
state: Arizona
city: Greenwood
country: United States
facility: Greenwood Leflore Hospital
state: Mississippi
city: Charlotte
country: United States
facility: Surgical Specialists of Charlotte
state: North Carolina
city: Pasadena
country: United States
facility: Flow Vascular, Surgery Specialty Hospitals of America
state: Texas
Study officials:
References: