Not Yet RecruitingNot Applicable

PATH-03 Paraguay Feasibility Study

Paraguay20 participantsStarted 2025-10

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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

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

What they're measuring

Primary Safety Endpoint

Timeframe: 3 months

Trial details

NCT IDNCT07034092

SponsorPathfinder Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Sorin C Popa, BESc, MRes

+44 (0) 7939186529 sorin@pathfindermed.com

View on ClinicalTrials.gov More Kidney Disease, End-Stage trials