First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft

End Stage Renal Disease Clinical Trial

— aXess-FIH  

Official title:

First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft (aXess)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04898153
• Other study ID #: XEL-CR-08
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: September 2027

Study information

• Verified date: July 2023
• Source: Xeltis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: September 2027
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• End Stage Renal Failure on Dialysis
• Kidney Failure, Chronic

Intervention

Device:
• aXess
Patients will be implanted with one Xeltis hemodialysis access device (aXess) in the arm

Locations

Country	Name	City	State
Belgium	A.Z. Sint Jan	Brugge
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	UZ Ghent	Ghent
Italy	Universita degli studi dell'Insubria	Varese
Latvia	P. Stradins Clinical University Hospital	Riga
Lithuania	Vilnius University Hospital Santaros Klinikos Corpus A.	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Xeltis

Countries where clinical trial is conducted

Belgium,  Italy,  Latvia,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from device related serious adverse events	The number of patients who have a device related serious adverse event	6 months
Primary	Functional patency of graft	The number of patients with a functionally patent graft	6 months
Secondary	Freedom from device related serious adverse events	The number of patients who have a device related serious adverse event	12, 18, 24, and 60 months
Secondary	Functional patency of graft	The number of patients with a functionally patent graft	12, 18, 24, and 60 months
Secondary	Patency (primary, primary assisted, and secondary) of graft	The number of patients with a patient graft	6, 12, 18, 24, and 60 months
Secondary	Time to potential central venous catheter removal	Time that patients with a central venous catheter could have had the catheter removed after the Xeltis hemodialysis access graft was placed	Assessed retrospectively at 30 days
Secondary	Time to loss of patency (primary, primary assisted, and secondary)	Number of days from implant to graft occlusion in patients who no longer have a patent graft	6, 12, 18, 24, and 60 months
Secondary	Rate of access related interventions required to achieve/maintain patency	Number of interventions that were performed on grafts to achieve/maintain patency	6, 12, and 24 months
Secondary	Rate of access site infections	Number of access graft sites that become infected	6, 12, and 24 months
Secondary	Proportion of hemodialysis (HD) sessions completed via central venous catheter	Number of hemodialysis sessions performed with a central venous catheter vs. the number of sessions performed with the Xeltis hemodialysis access graft	12 months
Secondary	Number of days with central venous catheter in place (catheter contact time)	Number of days the patients have a central venous catheter in place irrespective of access abandonment	12 months
Secondary	Pseudoaneurysm formation	Number of grafts that have a pseudoaneurysm form	6, 12, and 24 months