PATH-03 Paraguay Feasibility Study

NCT07034092 | Not Yet Recruiting

• 2 other identifiers: SKL-TF60000 10.4Pathfinder Medical
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Disease, End-Stage

Keywords

fistula, AVF, endoAVF, hemodialysis, vascular access; endovascular AVF

Outcome Measures

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.

  3 months

Secondary Outcomes (5)

• Technical Success

  7 days

• AVF maturation

  3 months

• Time to fistula maturation

  3 months

• Rate of other device or other procedure-related adverse events

  3 months

• Rate of device and/or procedure related infections

  3 months

Study Arms (1)

Intervention group

EXPERIMENTAL

An endoAVF will be created in the treated subjects.

Device: ePATH System will be used to create an endoAVF

Interventions

ePATH System will be used to create an endoAVF DEVICE

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pathfinder Medical: lead
• MINSA SA: collaborator

Study Sites (1)

Sanatorio Italiano

Asunción, 001207, Paraguay

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Study Officials

• Adrian A Ebner, MD

  Sanatorio Italiano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sorin C Popa, BESc, MRes

CONTACT

+44 (0) 7939186529; sorin@pathfindermed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An endoAVF for dialysis access will be created in the treated subjects.

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)