About this trial
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.
Eligibility criteria
Qualifiers
Thrombosed AVG in the upper arm
Successful thrombolysis of the thrombosed AVG, defined as the re-established of flow on Digital Subtraction Angiography (DSA) and restoration of thrill in the AVG on clinical examination (to be determined during procedure)
Disqualifiers
Patient unable to provide informed consent
Previous bare metal stent or stent-graft placement within the dialysis access
Previous treatment with DCB within 3 months
Presence of central vein stenosis which cannot be adequately treated (residual recoil of more than 30%)
Trial design
Treatments tested in this trial
- Sirolimus drug-coated balloon
- Stent graft
Treatment groups
Sponsors and collaborators
Singapore General Hospital
Lead sponsor
National Medical Research Council (NMRC), Singapore
Collaborator