Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT07034092
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07034092
Study Brief:
Protocol Section:
NCT07034092