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Sirolimus Coated Angioplasty Balloon in the Salvage of Thrombosed Arteriovenous Graft

NCT03666208 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-09-10

No results posted yet for this study

Summary

End stage renal disease is on increasing trend. Haemodialysis is the main dialysis modality among these patients which accounts for the incidence of 81.3% in 2015 based on data from Singapore renal registry. Thus, A functioning dialysis vascular access (either arteriovenous Fistula or graft) is critical to the delivery of life-saving haemodialysis treatment to these patients.

The main focus in our study is thrombosed (blocked) AVG as it has higher thrombosis rate and poorer patency rate. Conventionally, to restore the function of the dialysis access, the thrombus (clot) will be lysed with the use of lytic agent; followed by treatment of the underlying stenosis (narrowing) with plain balloon angioplasty (dilatation). However narrowing often recur and multiple repeated angioplasty procedures are needed keep the AVG flowing to prevent clots formation.

Recently developed balloons called drug eluting balloons, are coated with medications to prevent the narrowing from recurring after angioplasty. With these drug balloons, the AVG can potentially continue to have good flow for a longer period of time, hence, decreasing the chance of clotting. A newer generation of drug-eluting balloon, called sirolimus coated balloon, are coated with a medicine called sirolimus. It has been successfully used in the treatment of narrowing of vessels in the leg and heart and it were superior than conventional paclitaxel coated balloon angioplasty.

We hypothesis that sirolimus coated balloon is superior to conventional plain balloon angioplasty with decreased re-stenosis of target lesion, improved access circuit and target 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 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.

Sponsors & Collaborators

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Chieh Suai Tan, Doctor · Singapore General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2019-09-02
Completion
2019-09-02

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03666208 on ClinicalTrials.gov