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 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT04629118
Eligibility Criteria:
Inclusion Criteria:
* Patient aged ≥21 years and ≤90 years
* Native AVF was created more than 2 months prior to the index procedure and had undergone 10 or more haemodialysis sessions utilising two needles
* Target lesion location has to be located between the anastomoses to the auxiliary-subclavian vein junction, as defined by insertion of the cephalopods vein
* On initial fistulogram, target lesion stenosis has to be \>50% on angiographic assessment and in keeping with the clinical indicator for intervention
* Stenosis had to be \< 12cm in length (to allow for potential treatment with one DEB (length 15cm) only)
* Stenosis had to be initially treated successfully with a high-pressure plain balloon prior to DEB treatment as defined by:- (A) No clinically significant dissection (flow limiting) (B) No extravasated requiring treatment/Stenting (C) Residual stenosis ≤30% by angiographic measurement (D) Ability to completely efface the lesion waist using the pre-dilation CBA
* No more than one additional ("non-target") lesion in the access circuit that had to be also successfully treated (≤30% residual stenosis) before drug elation. Separate lesion was defined by at least 3cm in distance from the target lesion
* Reference vessel diameters allowed are 4mm - 7mm
Exclusion Criteria:
* Women who are pregnant, lactating or planning on becoming pregnant during study
* Subject has more than two lesions in the access circuit
* Subject had a secondary non-target lesion that could not be successfully treated
* Sepsis or active infection
* Asymptomatic target lesions
* A thrombosis access or an access with thrombosis treated ≤30 days prior to the index procedure
* Pseudoaneurysm in proposed target lesion area
* Surgical revision of the access site performed, planned or expected ≤3 months before or after the index procedure
* Patients who is taking immunosuppressive therapy or are routinely taking ≥15mg of prednisone per day
* Currently participating in another investigational drug, biologic, or device study involving Sirolimus or Paclitaxel
* Contraindication to aspirin or clopidogrel usage
* Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, or language barrier such that the subject is unable to give informed consent.
* Uncooperative attitude or potential for non-compliance with the requirements of the protocol making study participation impractical
* Where final angioplasty treatment requires a stent or drug eluting balloon \>8mm in diameter
* Metastatic cancer or terminal medical condition
* Blood coagulation disorders
* Limited life expectancy (\<12 months)
* Allergy or other known contraindication to iodinated media contrast, heparin, or Sirolimus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT04629118
Study Brief:
Protocol Section:
NCT04629118