PATH-03 Paraguay Feasibility Study

Pathfinder Medical

Status: Not yet enrolling

Conditions: Kidney Disease, End-Stage

Treatments: Device: ePATH System will be used to create an endoAVF

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07034092

SKL-TF60000 10.4

Pathfinder Medical (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Intervention group

Experimental group

Description:

An endoAVF will be created in the treated subjects.

Treatment:

Device: ePATH System will be used to create an endoAVF