Clinical trial NCT04898153: First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft
Official title: First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft (aXess)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: End Stage Renal Disease
End Stage Renal Failure on Dialysis
Lead sponsor: Xeltis
Sponsor class: INDUSTRY
First posted: 2021-05-24
Enrollment: 20
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 feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.

Detailed description: A prospective, single arm, non-randomized FIH feasibility study to evaluate the preliminary safety and performance of the Xeltis hemodialysis access graft 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, and are deemed not suitable for fistula creation by the operating surgeon.

Eligibility criteria: Inclusion Criteria:

* Subjects older than 18 years with end-stage renal disease (ESRD) who are not, or who are no longer, candidates for creation of an autogenous AV fistula, and therefore require placement of an AV graft in the upper extremity to start or maintain hemodialysis therapy
* Suitable anatomy 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 Criteria:

* History or evidence of severe cardiac disease (NHYA Functional Class IV and/or EF \<30%), myocardial infarction within six months of study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
* Stroke within six months before study entry
* Active clinically significant autoimmune / inflammatory disease, immunodeficiency (including AIDS / HIV), use of immunosuppressive therapy or medication that likely interferes with restorative therapies
* Abnormal blood values (e.g. leurkopenia with white blood cell (WBC) count \< 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
* Any active local or systemic infection (WBC \> 15,000/mm3)
* Uncontrolled or poorly controlled diabetes (hemoglovin A1c \> 8% despite standard care) or hospitalization for poor glucose control within the previous 6 months
* Reduced liver function, defined as: \>2x the upper limit of normal for serum bilirubin, aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase; International Normalized Ratio (INR) \> 1.5 or prothrombin time (PT) \> 18 seconds
* Known heparin-induced thrombocytopenia
* Active bleeding disorder and/or any coagulopathy or thrombo embolic disease
* History or evidence of severe peripheral vascular disease in the upper limbs
* 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 previous failed graft
* More than 1 failed dialysis access graft in the operative limb
* Anticipated renal transplant within 6 months
* Subjects receiving a forearm graft which crosses the elbow
* Allergies to study device (Nitinol) or agents/medication, such as contrast agents, aspirin, or clopidogrel, that cant be controlled medically
* Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
* Subject is participating in another study
* Previous enrollment in this study
* Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and efficacy of the study conduit

Primary outcomes:
measure: Freedom from device related serious adverse events
timeFrame: 6 months
measure: Functional patency of graft
timeFrame: 6 months
Secondary outcomes:
measure: Freedom from device related serious adverse events
timeFrame: 12, 18, 24, and 60 months
measure: Functional patency of graft
timeFrame: 12, 18, 24, and 60 months
measure: Patency (primary, primary assisted, and secondary) of graft
timeFrame: 6, 12, 18, 24, and 60 months
measure: Time to potential central venous catheter removal
timeFrame: Assessed retrospectively at 30 days
measure: Time to loss of patency (primary, primary assisted, and secondary)
timeFrame: 6, 12, 18, 24, and 60 months
measure: Rate of access related interventions required to achieve/maintain patency
timeFrame: 6, 12, and 24 months
measure: Rate of access site infections
timeFrame: 6, 12, and 24 months
measure: Proportion of hemodialysis (HD) sessions completed via central venous catheter
timeFrame: 12 months
measure: Number of days with central venous catheter in place (catheter contact time)
timeFrame: 12 months
measure: Pseudoaneurysm formation
timeFrame: 6, 12, and 24 months
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: A.Z. Sint Jan
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Ghent
country: Belgium
facility: UZ Ghent
city: Varese
country: Italy
facility: Universita degli studi dell'Insubria
city: Riga
country: Latvia
facility: P. Stradins Clinical University Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos Corpus A.
Study officials:
affiliation: UZ Ghent
name: Frank Vermassen, MD
role: PRINCIPAL_INVESTIGATOR
References: