Actively Recruiting
Sirolimus Drug-coated Balloon Versus Stent Graft
Led by Singapore General Hospital · Updated on 2023-12-26
100
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
S
Singapore General Hospital
Lead Sponsor
N
National Medical Research Council (NMRC), Singapore
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sirolimus Drug-coated Balloon Versus Stent Graft
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Singapore General Hospital
Singapore, Singapore
Actively Recruiting
Research Team
R
Ru Yu Tan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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