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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT04627051
Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant, non-breastfeeding female ≥18 years of age;
* Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits;
* Target lesion must be a mature arteriovenous graft presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines;
* Subject has a target lesion at the venous anastomosis of the AVG;
* Successful crossing of the stenosis;
* Each lesion length is ≤20mm, which may include tandem lesions that are ≤20mm apart
Exclusion Criteria:
* Subject is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this study;
* Subject has a non-controllable allergy to contrast;
* Subject has more than 3 lesions in the access circuit requiring intervention;
* Target lesion diameter \>10mm;
* A thrombosed access or an access with a thrombosis treated ≤30 days prior to the index procedure;
* Prior surgical interventions of the access site ≤30 days before the index procedure;
* Target lesion is located within a bare metal or covered stent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04627051
Study Brief:
Protocol Section:
NCT04627051