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:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT02682420
Eligibility Criteria:
Inclusion Criteria:
* Adult (age \>18 years old)
* Currently on chronic dialysis or expected to be started on chronic dialysis within 3 months of planned endoAVF creation
* Target treatment vein diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Venogram
* Target treatment artery diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Arteriogram
* Both radial and ulnar artery flow to the hand, as confirmed with Duplex Ultrasound and/or Allen's test (i.e.: palmar arch)
Exclusion Criteria:
* Known central venous stenosis or central vein narrowing \> 50% based on imaging on the same side as the planned AVF creation
* Absence of perforator feeding the target cannulation vein(s) via Venogram
* Occlusion or stenosis \>50% of target cannulation cephalic or basilic vein
* Significantly compromised (≥50% stenosis) flow in the treatment arm
* Documented ejection fraction (EF) ≤35% in the last 6 months
* Pregnant women
* New York Heart Association (NYHA) class III or IV heart failure
* Hypercoagulable state
* Known bleeding diathesis
* Documented history of drug abuse including intravenous drugs within six months of AVF creation
* "Planned" concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment
* Known allergy to contrast dye which cannot be adequately pre-medicated
* Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated
* Evidence of active infections on the day of the index procedure
* Estimated life expectancy \< 1 year
* Patient is not willing to provide written informed consent, is not geographically stable and/or not willing to comply with required follow-up
* Patient with a target cannulation vein that is \> 6mm deep that would require a transposition procedure, defined as the elevation of a target cannulation vein AND the creation of a new AV fistula
* Patient is not willing to undergo a 2nd stage procedure as defined in Section 4.5.3 of the study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02682420
Study Brief:
Protocol Section:
NCT02682420