Dysfunctional Dialysis Arteriovenous Fistula
Conditions
Brief summary
Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis arteriovenous fistulas (AVFs).
Detailed description
Objectives of the Study: Hypothesis: Drug-coated balloons improve functional and patency outcomes of failing/dysfunctional hemodialysis fistulas compared to plain uncoated balloons Aim of the Study: Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis AVFs. Specific Objectives: Primary functional endpoint: Access circuit patency based on functional criteria at 12 month. Primary safety endpoint: Peri procedural complication rate Secondary endpoints: * Technical success (\<30% residual stenosis without postdilation) * Access circuit dysfunction free survival (Time to event) based on functional criteria * Target lesion restenosis free survival (Time to event) (in case of new lesion causes circuit dysfunction)
Interventions
DEVICEVessel preparation with angioplasty
Vessel preparation with Pre dilatation: * All lesions to be predilated with high pressure balloons until waist is obliterated. * At least two minutes dilatation. * Balloon sizing: not to exceed the average diameter of adjacent normal appearing non-aneurysmal segments by more than 25%. * Multiple lesions: * To be treated with single balloon if possible. * To be treated with multiple inflation if cannot be covered with single balloon.
Plain balloon angioplasty * Vessel treatment with additional Plain balloon angioplasty: * Inflation to nominal pressure for at least 1 minute. * Balloon size: similar to predilation balloon.
Lutonix® Drug Coated Balloon: The balloon is coated with a specialized formulation that includes the drug, paclitaxel. The paclitaxel coating is evenly distributed across the working length of the balloon at a surface concentration of 2 μg/mm2. The key functional characteristic of the formulation is to allow for release of paclitaxel to the tissue of the vascular wall during inflation. * Inflation to nominal pressure for at least 1 minute. * Balloon size: similar to the predilation balloon. * New drug coated balloon will be required for each lesion.
Sponsors
King Abdullah International Medical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AVF circuit patency | 12 month | Dialysis adequacy to be assessed based on functional criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Access circuit dysfunction free survival | 12 month | Time to event based on functional criteria |
| Target lesion restenosis free survival | 12 month | Time to event in case of new lesion causes circuit dysfunction |
| Number of participants with treatment-related adverse events | 12 month following the procedure | Number of participants with treatment-related adverse events as assessed by the Society of Interventional Radiology Clinical Practice Guidelines |
| Technical success | intra procedural | \<30% residual stenosis without postdilation |
Countries
Saudi Arabia
Outcome results
None listed