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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT03189667
Eligibility Criteria:
Inclusion Criteria:
* Inclusion criteria
* \>18 year old
* Dysfunctional dialysis fistula
* Radiocephalic
* Brachiocephalic
* Brachiobasilic
Clinical criteria for diagnosis of dysfunctional fistula:
* Swelling of the fistula limb
* Prolonged bleeding after withdrawing access needles
* Abnormal pulsations or weak thrill.
* Functional criteria for the diagnosis of dysfunctional criteria:
* Arteriovenous fistula is unable to deliver dialysis blood flow (Qb) of equal to or more than 300 ml/min and/or access recirculation of more than 10% on at least two occasions,
* A rising trend of venous pressure or excessive negative arterial pressure, and/or unable to deliver a Kt/v of 1.2 or more.
* Non-thrombosed
Exclusion Criteria:
* Dysfunctional arteriovenous (AV) grafts
* Thrombosed fistulas
* Intra-stent stenosis
* Stenoses not responding to balloon angioplasty and requiring stenting.
* Stenosis less than 50%
* Surgical intervention that excludes the treatment segment from the access circuit
* Systemic or local (to the fistula) infection treated for less than 10 days prior to the study procedure
* Location of isolated stenosis central to the thoracic inlet.
* Women who are breastfeeding, pregnant or are intending to become pregnant
* Known hypersensitivity or contraindication to contrast medium which cannot be adequately premeditated.
* Sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03189667
Study Brief:
Protocol Section:
NCT03189667