Sirolimus Drug-coated Balloon Versus Stent Graft
Recruiting now · Not applicable
Conditions studied: Arteriovenous Shunt Thrombosis, Blood Vessel Prosthesis
In brief
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.
Key facts
- Study ID
- NCT05938530
- Run by
- Singapore General Hospital
- People needed
- 100
- Starts
- 2023-11-01
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2023-12-26
Who can join
Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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%)
- Failure to re-establish blood flow
- Failure to adequately treat the GV junction (defined as residual stenosis of more than 30%)
- Sepsis or active infection
- Recent intracranial bleed or gastrointestinal bleed within the past 12 months
- Allergy to iodinated contrast media, anti-platelet drugs, heparin or sirolimus
- Pregnancy
- Life expectancy < 12 months based on physician's estimate (eg. active malignancy)
Where it is running
- Singapore General Hospital — Singapore, Singapore (enrolling)
Full record on ClinicalTrials.gov
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