Sirolimus Drug-coated Balloon Versus Stent Graft
Sirolimus Drug-coated Balloon Versus Stent Graft for Thrombosed Arteriovenous Graft (SUSTAIN)
Singapore General Hospital
100 participants
Nov 1, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- 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)
Exclusion Criteria11
- 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)
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Interventions
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 has been shown to be superior than plain balloon angioplasty in the treatment of AVG dysfunction.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05938530