Sirolimus Drug-coated Balloon Versus Stent Graft

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorSingapore General Hospital

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

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Singapore General Hospital

Lead sponsor

National Medical Research Council (NMRC), Singapore

Collaborator