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 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT01921933
Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant female (verified with a urine/blood pregnancy test, for women of reproductive age).
* Life expectancy of at least one year, per the investigator's opinion.
* Diagnosed with ESRD or chronic kidney disease requiring dialysis.
* Planned upper extremity autogenous arteriovenous fistula.
* Planned anastomosis is an end of vein to side of artery configuration.
* AVF target artery and vein inner diameters are greater or equal to 3.0 mm and less than or equal to 7.0 mm as determined by pre-operative ultrasound and confirmed intra-operatively.
* Patient is available and willing to return for follow-up visits during the duration of the study.
* Patient is able and willing to follow a daily aspirin and/or other anticoagulation/antiplatelet regimen not including warfarin (see exclusion criteria).
* Patient, or their legal representative, is willing and able to provide informed consent.
Exclusion Criteria:
* Known bleeding diathesis or coagulation disorder.
* Documented or suspected central venous stenosis.
* Uncontrolled hypotension with systolic blood pressures \< 100 mg Hg at the time of screening.
* Peripheral white blood cell count \< 1.5 K/mm3 or platelet count \< 75,000 cells/mm3.
* Body Mass Index (BMI) \> 42.
* Transposition of the access vein is anticipated within the 90 day follow-up interval.
* Receiving anticoagulant therapy for non-cardiac indications.
* Evidence or history of an active or suspected infection within one month of screening.
* Scheduled kidney transplant within six months of enrollment.
* History of ≥ 2 AVF and/or synthetic access graft failures.
* History of steal syndrome from a previous hemodialysis vascular access which required intervention or abandonment.
* Current participation in another clinical trial (excluding retrospective studies or studies not requiring a consent form).
* Anticipated surgery requiring general anesthesia during the course of follow-up.
* A history of substance abuse.
* Anticipated to be non-compliant with medical care or study requirements based on investigator judgment.
* Need for immunosuppressive therapy at a dose greater than the equivalent of prednisone 10 mg per day.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01921933
Study Brief:
Protocol Section:
NCT01921933