Sirolimus Coated Angioplasty Balloon in the Salvage of Thrombosed Arteriovenous Graft

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

July 1, 2018

Primary Completion Date

September 2, 2019

Study Completion Date

September 2, 2019

Conditions
End Stage Renal Failure on DialysisArteriovenous Graft Occlusion
Interventions
DEVICE

Sirolimus Coated Balloon

"Sirolimus has been used in organ transplantation as well as coronary stent due to its antiproliferative properties. It has been proven to has better outcome in animal studies compared to paclitaxel, which is about 22% in the sirolimus group versus 75% re-stenosis rate in paclitaxel group.~Sirolimus is coated on the surface of the angioplasty balloon and is transferred to the vessel wall when balloon is inflated and in contact with the vessel wall.~The following table compare sirolimus to paclitaxel. In which sirolimus works by cytostatic mechanism with a ten thousand fold of safety margin. And sirolimus's anti-restenosis effect is optimal with the benefit of lower level of competition and lesser tissue absorption and elution."

Trial Locations (1)

169608

Singapore General Hospital Renal Department, Singapore

All Listed Sponsors
lead

Singapore General Hospital

OTHER

NCT03666208 - Sirolimus Coated Angioplasty Balloon in the Salvage of Thrombosed Arteriovenous Graft | Biotech Hunter | Biotech Hunter