Kidney Disease, End-Stage
Conditions
Keywords
fistula, AVF, endoAVF, hemodialysis, vascular access, endovascular AVF
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.
Interventions
DEVICEePATH System will be used to create an endoAVF
An endoAVF will be created in subjects that need fistulas for hemodialysis
Sponsors
Pathfinder Medical
MINSA SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
An endoAVF for dialysis access will be created in the treated subjects.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | 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
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | 7 days | 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. |
| AVF maturation | 3 months | 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 to fistula maturation | 3 months | Number of days between the index procedure and the date at which AVF maturation is achieved |
| Rate of other device or other procedure-related adverse events | 3 months | 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 |
| Rate of device and/or procedure related infections | 3 months | Rate of device and/or procedure related infections at 3 months following the index procedure |
Countries
Paraguay
Contacts
CONTACTSorin C Popa, BESc, MRes
PRINCIPAL_INVESTIGATORAdrian A Ebner, MD
Sanatorio Italiano
Outcome results
None listed