PATH-03 Paraguay Feasibility Study

Inclusion criteria

• Patients deemed eligible for creation of an AV fistula according to institutional or local guidelines and/or clinical judgement of the investigator
• Adults (age >18 years old)
• Non-reversible kidney failure requiring hemodialysis (this can include pre-dialysis patients)
• Target vein diameter of ≥2.0 mm
• Target artery diameter of ≥2.0 mm
• Both radial and ulnar artery flow to the hand, confirmed with Duplex Ultrasound and/or Allen's test (i.e. palmar arch)
• Able to provide informed consent
• Able to comply with follow-up visit assessment requirements
• Patient is free from clinically significant conditions or illnesses that might compromise the procedure or the AVF

Exclusion criteria

• Significant central venous stenosis or narrowing that exceeds 50% based on imaging
• Hypercoagulable state or known bleeding diathesis
• NHYA Class III or IV heart failure
• Estimated life-expectancy of <1 year based on the physician's opinion
• Oedema of extremities
• Current diagnosis of carcinoma
• Pregnant or breastfeeding women
• Diagnosed or suspected skin disease at the access site
• Immunosuppression or otherwise immunocompromised patients
• Currently being treated with another investigational device or medication
• Allergy to contrast or other drugs associated with surgery, e.g., sedation agents, or to device materials
• Anatomy that prevents formation of AVF, e.g., misalignment of vessels or tortuosity
• Patient is unwilling to undergo 2nd stage procedure, e.g. endovascular prothesis placement or balloon dilatation, if required