Sirolimus Coated Angioplasty Versus Plain Balloon Angioplasty
Singapore170 participantsStarted 2021-01-11
Plain-language summary
A functioning dialysis access is critical to the delivery of hemodialysis therapy in patients with End Stage Renal Disease. Stenosis secondary to neo-intimal hyperplasia frequently occur within the dialysis access, resulting in dysfunction. Conventional balloon angioplasty is the current standard of care for treatment of stenosis but is associated with high rate of recurrence. Paclitaxel coated balloon has been shown to be superior to conventional balloon angioplasty in dialysis access interventions but recent meta-analysis has shown an increase in mortality when paclitaxel coated balloon and stents are used in lower limb angioplasty. Sirolimus coated angioplasty balloon are second generation drug coated balloon that have been shown to be effective in coronary artery interventions. Sirolimus is cytostatic in nature with good safety profile. In our pilot study, sirolimus coated balloon has been shown to be safe and effective in the salvaged of thrombosed arteriovenous graft. Therefore, the investigators are conducting a double-blinded, multi-center randomised control trial to compare the 6 month patency of arteriovenous fistula after intervention with sirolimus coated balloon versus conventional balloon angioplasty.
The investigators hypothesise that the addition of SCB after successful balloon angioplasty with conventional plain balloon is superior to conventional plain balloon angioplasty alone with decreased restenosis of the treated lesion, improved access circuit and treated lesion patency, and decreased number of interventions needed to maintain patency.
Who can participate
Age range21 Years – 85 Years
SexALL
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Inclusion criteria
✓. Age 21 to 85 years
✓. Patient who requires balloon angioplasty for dysfunction arteriovenous fistula
✓. Matured AVF, defined as being in use for at least 1 month prior to angioplasty
✓. 4\. Successful angioplasty of the underlying stenosis, defined as less than 30% residual stenosis on Digital Subtraction Angiography (DSA) based on visual assessment of the operator and restoration of thrill in the AVF on clinical examination. (For concurrent asymptomatic or angiographically not significant central vein stenosis, patients can be included if no treatment is required.)
Exclusion criteria
✕. Patient unable to provide informed consent
✕. Thrombosed or partially thrombosed AVF
✕. Presence of symptomatic or angiographically significant central vein stenosis who require treatment, with more than 30% residual stenosis post angioplasty
✕. Patients who had underwent stent placement within the AVF circuit