PATH-03 Paraguay Feasibility Study
ConditionKidney Disease, End-Stage
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPathfinder Medical
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ePATH System will be used to create an endoAVF
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Pathfinder Medical
Lead sponsor
MINSA SA
Collaborator
Source ClinicalTrials.gov