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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 85
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Singapore
Singapore General Hospital
RECRUITING
Singapore
Contact Information
Primary
Ru Yu Tan
tan.ru.yu@singhealth.com.sg
+6563214436
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2026-08
Participants
Target number of participants: 100
Treatments
Experimental: Sirolimus drug-coated balloon
The trial product is MagicTouch sirolimus drug coated balloon (Concept Medical). Sirolimus will be transferred from the balloon to the graft vein junction by inflating the balloon for 2 minutes at rated burst pressure (typically 12 to 14ATM).
Active_comparator: Stent graft
Stent graft is the current standard of care for treatment of arteriovenous graft malfunction. A stent graft will be deployed at the graft vein junction.
Related Therapeutic Areas
Sponsors
Leads: Singapore General Hospital
Collaborators: National Medical Research Council (NMRC), Singapore

This content was sourced from clinicaltrials.gov