Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis arteriovenous fistulas (AVFs).
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
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.
King ABdulaziz Medical City
Riyadh, Saudi Arabia
AVF circuit patency
Dialysis adequacy to be assessed based on functional criteria
Time frame: 12 month
Technical success
\<30% residual stenosis without postdilation
Time frame: intra procedural
Access circuit dysfunction free survival
Time to event based on functional criteria
Time frame: 12 month
Target lesion restenosis free survival
Time to event in case of new lesion causes circuit dysfunction
Time frame: 12 month
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by the Society of Interventional Radiology Clinical Practice Guidelines
Time frame: 12 month following the procedure
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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.