PATH-03 Paraguay Feasibility Study

Feasibility Study to Evaluate the Safety and Efficacy of the ePATH System for endoAVF Creation

The goal of this study is to evaluate the safety and effectiveness of the ePATH system in the creation of an endovascular AVF (endoAVF) in patients who require or will soon require hemodialysis and are eligible for a fistula.

Inclusion Criteria:

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

Exclusion Criteria:

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