Arteriovenous Graft Occlusion clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT04409912 Recruiting - Clinical trials for End Stage Renal Failure on Dialysis

Sirolimus Coated Angioplasty Versus Plain Balloon Angioplasty

IMPRESSION

Start date: January 11, 2021
Phase: N/A
Study type: Interventional

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.