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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT05360394
Eligibility Criteria:
Inclusion Criteria:
* Age 21 - 90 years
* Patients who requires balloon angioplasty for dysfunctional arteriovenous fistula, can be de novo lesions or recurrent CAS stenosis within six months of interventions. Suitability will be determined with a baseline ultrasound assessment.
* Matured AVF, defined as being in use for at least 1 month prior to angioplasty
* Successful angioplasty of the underlying stenosis, defined as less than 30% residual stenosis on Digital Subtraction Angiography (DSA).
Exclusion Criteria:
* Patient unable to provide informed consent
* Thrombosed or partially thrombosed AVF
* Immature AVF
* Insignificant CAS defined as \<50% stenosis and no clinical indicator such as high V pressure.
* Presence of central vein stenosis with more than 30% residual stenosis post-angioplasty
* Patient who had underwent stent placement within the CAS previously
* Patients who are allergic to both aspirin or clopidogrel
* Patient who are currently enrolled in other drug eluting balloon trials
* Sepsis or active infection
* Recent intracranial bleed or gastrointestinal bleed within the past 12 months.
* Allergy to iodinated contrast media, heparin or paclitaxel
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT05360394
Study Brief:
Protocol Section:
NCT05360394