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Not yet recruiting NCT07034092

PATH-03 Paraguay Feasibility Study

No phase Interventional Kidney Disease, End-Stage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ePATH System will be used to create an endoAVF.
Who it may be relevant to
Registry conditions: Kidney Disease, End-Stage. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Paraguay
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device ePATH System will be used to create an endoAVF
    An endoAVF will be created in subjects that need fistulas for hemodialysis

Primary outcome measures

  • Primary Safety Endpoint [Time frame: 3 months]
Secondary outcome measures (5)
  • Technical Success [Time frame: 7 days]
  • AVF maturation [Time frame: 3 months]
  • Time to fistula maturation [Time frame: 3 months]
  • Rate of other device or other procedure-related adverse events [Time frame: 3 months]
  • Rate of device and/or procedure related infections [Time frame: 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

Paraguay · 1 center
  • Sanatorio Italiano — Asunción

Identifiers

NCT: NCT07034092 · SKL-TF60000 10.4 · Pathfinder Medical

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗