RecruitingNot ApplicableNCT05938530

Sirolimus Drug-coated Balloon Versus Stent Graft

Sirolimus Drug-coated Balloon Versus Stent Graft for Thrombosed Arteriovenous Graft (SUSTAIN)


Sponsor

Singapore General Hospital

Enrollment

100 participants

Start Date

Nov 1, 2023

Study Type

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

Min Age: 21 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Sirolimus drug-coated balloon and a medical device called Stent graft for people with arteriovenous shunt thrombosis and blood vessel prosthesis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 21 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESirolimus 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.

DEVICEStent 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

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NCT05938530


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