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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT04540302
Eligibility Criteria:
Inclusion Criteria:
* Subject provides written informed consent
* Subject is male or female, with an age ≥ 18 years at date of enrollment.
* Subject is willing to undergo all follow-up assessments.
* Subject has a life expectancy ≥ 12 months.
* Subject is undergoing chronic hemodialysis.
* Subject has either a mature AVF or AVG in the arm.
* Target lesion(s) involves a de novo stenotic or non-stented restenotic lesion.
* Target lesion has ≥50% stenosis.
* Target lesion(s) reference vessel diameter is between 5.0 mm and 14.0 mm
Exclusion Criteria:
* Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
* Subject has a stroke diagnosis within 3 months prior to enrollment.
* Subject has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
* Subject is pregnant, breastfeeding, or intending to become pregnant within the next year.
* Target lesion is located within a stent / stent graft.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04540302
Study Brief:
Protocol Section:
NCT04540302