Health Trials

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • ePATH System will be used to create an endoAVF

    Device

    An endoAVF will be created in subjects that need fistulas for hemodialysis

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary Safety Endpoint

Proportion of patients that experience one or more serious ePATH device-related or ePATH portion of the procedure-related adverse events during the first 3 months following AVF creation.

Time frame
3 months

Secondary outcomes

1

Technical Success

Technical success: Successful creation of a fistula with the ePATH system. Verification that an endoAVF has been created with the ePATH system and that it remains patent 1-7 days after the index procedure. Patency will be defined by an experienced examiner as the presence of a bruit as detected by stethoscope, or the presence of a thrill, or with duplex ultrasonography for all study endpoints.

Time frame
7 days
2

AVF maturation

Defined as an AVF that is free from stenosis or thrombosis with an arterial inflow of at least 500 ml/min and/or a diameter of at least 4 mm (as measured by duplex ultrasonography) or the patient was successfully dialysed with 2 needles.

Time frame
3 months
3

Time to fistula maturation

Number of days between the index procedure and the date at which AVF maturation is achieved

Time frame
3 months
4

Rate of other device or other procedure-related adverse events

Rate of serious other device (not ePATH device) or other procedure-related (not ePATH portion of the procedure) adverse events at 3 months following the index procedure

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pathfinder Medical

Lead sponsor

MINSA SA

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: