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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT02513303
Eligibility Criteria:
Inclusion Criteria:
* Currently on hemodialysis for ≤12 months or expected to initiate hemodialysis within approximately 6 months of the creation of the AV fistula.
* Vascular anatomy suitable for creation of the AV fistula, determined by pre procedure duplex ultrasound
* Successful creation of a single stage radiocephalic or brachiocephalic end to side fistula
Exclusion Criteria:
* Prior AV access created on the limb where the fistula surgery is planned
* ST-elevation MI or cerebrovascular accident within 30 days of the index procedure
* Known hypersensitivity to the following: sirolimus, beef or bovine collagen
* Hypotension with systolic blood pressures \<100 mm Hg at the time of screening
* Known or suspected active infection at the time of the AV fistula surgery
* Known to be HIV positive
* Prisoner, mentally incompetent, and/or alcohol or drug abuser
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02513303
Study Brief:
Protocol Section:
NCT02513303