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Clinical Trials/NCT07034092
NCT07034092Not yet recruitingNot Applicable

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

Pathfinder Medical3 sites in 1 country20 target enrollmentStarted: March 1, 2027Last updated:
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Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
20
Locations
3
Primary Endpoint
Primary Safety Endpoint
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Device Feasibility
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Intervention group

Experimental

An endoAVF will be created in the treated subjects.

Intervention: ePATH System will be used to create an endoAVF (Device)

Outcomes

Primary Outcomes

Primary Safety Endpoint

Time Frame: 3 months

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor
Pathfinder Medical
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (3)

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