First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft
- Conditions
- End Stage Renal Failure on DialysisEnd Stage Renal Disease
- Interventions
- Device: aXess
- Registration Number
- NCT04898153
- Lead Sponsor
- Xeltis
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description aXess aXess Patients will be implanted with the Xeltis hemodialysis access graft (aXess)
- Primary Outcome Measures
Name Time Method Freedom from device related serious adverse events 6 months The number of patients who have a device related serious adverse event
Functional patency of graft 6 months The number of patients with a functionally patent graft
- Secondary Outcome Measures
Name Time Method Time to loss of patency (primary, primary assisted, and secondary) 6, 12, 18, 24, and 60 months Number of days from implant to graft occlusion in patients who no longer have a patent graft
Proportion of hemodialysis (HD) sessions completed via central venous catheter 12 months Number of hemodialysis sessions performed with a central venous catheter vs. the number of sessions performed with the Xeltis hemodialysis access graft
Functional patency of graft 12, 18, 24, and 60 months The number of patients with a functionally patent graft
Freedom from device related serious adverse events 12, 18, 24, and 60 months The number of patients who have a device related serious adverse event
Patency (primary, primary assisted, and secondary) of graft 6, 12, 18, 24, and 60 months The number of patients with a patient graft
Time to potential central venous catheter removal Assessed retrospectively at 30 days Time that patients with a central venous catheter could have had the catheter removed after the Xeltis hemodialysis access graft was placed
Rate of access site infections 6, 12, and 24 months Number of access graft sites that become infected
Pseudoaneurysm formation 6, 12, and 24 months Number of grafts that have a pseudoaneurysm form
Rate of access related interventions required to achieve/maintain patency 6, 12, and 24 months Number of interventions that were performed on grafts to achieve/maintain patency
Number of days with central venous catheter in place (catheter contact time) 12 months Number of days the patients have a central venous catheter in place irrespective of access abandonment
Trial Locations
- Locations (6)
Ziekenhuis Oost-Limburg
🇧🇪Genk, Belgium
A.Z. Sint Jan
🇧🇪Brugge, Belgium
Vilnius University Hospital Santaros Klinikos Corpus A.
🇱🇹Vilnius, Lithuania
UZ Ghent
🇧🇪Ghent, Belgium
Universita degli studi dell'Insubria
🇮🇹Varese, Italy
P. Stradins Clinical University Hospital
🇱🇻Riga, Latvia