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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT04484220
Eligibility Criteria:
Inclusion Criteria:
1. Male or non-pregnant female ≥ 18 years of age and ≤ 80 years of age
2. Life expectancy of at least one year, in the investigator's opinion
3. Diagnosed with ESRD or chronic kidney disease on hemodialysis.
4. Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment
5. Adequate quality vein based on pre-operative assessment
1. Adjacent vein diameter of ≥2.0 mm at target anastomosis site
2. Confirmed clinically significant outflow
6. Adequate quality radial artery based on pre-operative assessment
a. Arterial lumen diameter of ≥2.0 mm at target anastomosis site
7. Adequate collateral arterial perfusion with patent palmar arch as demonstrated by Barbeau Test or Allen's Test.
8. Radial artery-adjacent vein proximity ≤1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure
9. Patient is able to provide written informed consent and attend follow-up examinations at the enrolling institution
Imaging-based Inclusion Criteria:
10. Confirm radial artery-adjacent vein proximity ≤1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedurally
11. Confirm radial artery and adjacent vein diameter of ≥2.0 mm at target anastomosis site
Exclusion Criteria:
1. Pre-existing ipsilateral vascular disease interfering with the study procedure or potentially confounding the study results including:
1. Documented or suspected central venous stenosis (≥ 50%) or
2. Upper extremity arterial stenosis or
3. Vascular disease at the radial artery / adjacent vein site
2. Prior vascular surgery at or proximal (central) to the AVF target site interfering with AVF maturation or other ipsilateral surgery that could potentially confound the study results such as prior axillary dissection or mastectomy
3. History of steal syndrome from a previous surgical ipsilateral hemodialysis vascular access which required intervention or abandonment
4. Systolic pressures \< 100 mg Hg at the time of screening
5. Suspected or confirmed skin disease at the skin entry site
6. Edema of the upper extremity on the ipsilateral side
7. Immunocompromised subjects due to underlying disease or immunosuppressant therapy such as sirolimus (Rapamune®) or Prednisone at a dose of \> 10 mg per day
8. Known bleeding diathesis, coagulation disorder or medications putting the subject at increased risk, in the Investigator's judgment
9. Patients with acute or active infection
10. Scheduled kidney transplant within 6 months of enrollment
11. Participation in another clinical investigation (excluding retrospective studies or studies not requiring a consent form)
12. History of substance abuse or anticipated to be non-compliant with medical care or study requirements based on investigator judgment
13. Patient has an active COVID-19 infection with ongoing sequela or hospitalization for treatment of COVID-19.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04484220
Study Brief:
Protocol Section:
NCT04484220