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Sirolimus Drug-coated Balloon Versus Stent Graft
Sponsor: Singapore General Hospital
Summary
A functioning dialysis vascular access is critical to the delivery of lifesaving hemodialysis. Arteriovenous graft (AVG) is a surgically created vascular access used for hemodialysis in patients with end-stage renal disease. AVG thrombosis due to underlying flow-limiting stenosis of the graft vein junction and outflow veins is a common complication. Thrombosed AVG can be treated with thrombolysis combined with percutaneous transluminal angioplasty with good immediate success rates. However, the mid-to-long term patency rates following angioplasty have been suboptimal. Sirolimus drug-coated balloon has been shown to be safe and effective in the salvage of thrombosed arteriovenous graft. The investigators hypothesize that sirolimus drug-coated balloon is non-inferior to stent graft in maintaining the patency of thrombosed AVG that is successfully salvaged. This study is conducted to compare the 6-month access circuit primary patency of thrombosed AVG treated with sirolimus drug-coated balloon versus stent graft.
Official title: Sirolimus Drug-coated Balloon Versus Stent Graft for Thrombosed Arteriovenous Graft (SUSTAIN)
Key Details
Gender
All
Age Range
21 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-11-01
Completion Date
2026-08
Last Updated
2023-12-26
Healthy Volunteers
No
Interventions
Sirolimus drug-coated balloon
The effectiveness of sirolimus coated balloon in patients with dialysis access dysfunction has been shown in a small pilot study in the salvage of thrombosed arteriovenous graft.
Stent graft
Stent graft has been shown to be superior than plain balloon angioplasty in the treatment of AVG dysfunction.
Locations (1)
Singapore General Hospital
Singapore, Singapore