Sirolimus Coated Angioplasty Versus Plain Balloon Angioplasty

Summary

A functioning dialysis access is critical to the delivery of hemodialysis therapy in patients with End Stage Renal Disease. Stenosis secondary to neo-intimal hyperplasia frequently occur within the dialysis access, resulting in dysfunction. Conventional balloon angioplasty is the current standard of care for treatment of stenosis but is associated with high rate of recurrence. Paclitaxel coated balloon has been shown to be superior to conventional balloon angioplasty in dialysis access interventions but recent meta-analysis has shown an increase in mortality when paclitaxel coated balloon and stents are used in lower limb angioplasty. Sirolimus coated angioplasty balloon are second generation drug coated balloon that have been shown to be effective in coronary artery interventions. Sirolimus is cytostatic in nature with good safety profile. In our pilot study, sirolimus coated balloon has been shown to be safe and effective in the salvaged of thrombosed arteriovenous graft. Therefore, the investigators are conducting a double-blinded, multi-center randomised control trial to compare the 6 month patency of arteriovenous fistula after intervention with sirolimus coated balloon versus conventional balloon angioplasty.

The investigators hypothesise that the addition of SCB after successful balloon angioplasty with conventional plain balloon is superior to conventional plain balloon angioplasty alone with decreased restenosis of the treated lesion, improved access circuit and treated lesion patency, and decreased number of interventions needed to maintain patency.

Conditions

• End Stage Renal Failure on Dialysis
• Arteriovenous Graft Occlusion

Interventions

DEVICE

Sirolimus coated balloon

Sirolimus has a high transfer rate to the vessel wall and effectively inhibit neointimal hyperplasia in the porcine coronary model. In coronary artery interventions, preliminary clinical studies using sirolimus coated balloon have shown excellent procedural and 6 month patency. 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. When compared to Paclitaxel, sirolimus is cytostatic in its mode of action with a high margin of safety.

DEVICE

Plain balloon

Plain balloon angioplasty is the current standard therapy to treat stenosis in dialysis access. However, the mid and long term patency of plain balloon angioplasty in patients with end stage renal disease is poor. The average primary patency is around 40 to 50 percent at 1 year and multiple repeated angioplasty is required to maintain the patency of the vascular access.

Sponsors & Collaborators

• National University Hospital, Singapore

  collaborator OTHER

• Sengkang General Hospital

  collaborator OTHER

• Singapore General Hospital

  lead OTHER

Principal Investigators

• Chieh Suai Tan, MD · Singapore General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-11

Primary Completion

2023-10-31

Completion

2024-10-31

Countries

• Singapore

Study Locations