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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT05616104
Eligibility Criteria:
Inclusion Criteria:
1. Subject is ≥18 years of age.
2. Subject is currently scheduled to undergo an endovascular intervention of arteriovenous fistula or graft due to clinical and hemodynamic abnormalities meeting the KDOQI Guidelines for AV access dysfunction:
* Elevated venous pressure during hemodialysis,
* Abnormal physical findings, and
* Unexplained decrease in delivered dialysis dose.
3. Subject has a reasonable expectation of remaining on hemodialysis for ≥12 months.
4. Subject is legally competent, informed of the study, voluntarily agrees to participate, and signs the informed consent form.
5. Subject understands the study and is willing and able to comply with the follow-up requirements.
Exclusion Criteria:
1. Subject has a known or suspected systemic infection.
2. Subject has a known or suspected infection of the hemodialysis graft.
3. Subject has an untreatable allergy to radiographic contrast material.
4. In the opinion of the operating physician, the subject's hemodialysis access is unsuitable for endovascular treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05616104
Study Brief:
Protocol Section:
NCT05616104