Health TrialsbyHealthPanel

Sirolimus Drug-coated Balloon Versus Stent Graft

ConditionsArteriovenous Shunt ThrombosisBlood Vessel Prosthesis
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Sirolimus drug-coated balloon

    Device

    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.

  • Stent graft

    Device

    Stent graft has been shown to be superior than plain balloon angioplasty in the treatment of AVG dysfunction.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Sirolimus drug-coated balloonExperimental treatment 1 intervention
Group B: Stent graftActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Access circuit primary patency of AVG at 6-months

This is measured by the percentage of patients whose AVG remain patent at 6 months after the procedure

Time frame
6 months

Secondary outcomes

1

Access circuit primary patency of AVG at 12-months

This is measured by the percentage of patients whose AVG remain patent at 12 months after the procedure

Time frame
12 months
2

Target lesion primary patency at 6- and 12-months

This is measured by the percentage of patients whose graft vein junction of AVG remain intervention-free at 6 and 12 months

Time frame
6 and 12 months
3

The number of interventions needed to maintain patency of AVG at 12 months

Total number of repeat interventions to treat the AVG in 12 months

Time frame
12 months
4

The technical and clinical success rates of the procedures

The percentage of patients who have successful re-establishment of flow in AVG (technical success) and undergo hemodialysis at prescribed blood flow for the prescribed duration (clinical success)

Time frame
Immediately after the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Singapore General Hospital

Lead sponsor

National Medical Research Council (NMRC), Singapore

Collaborator

Source ClinicalTrials.gov
Apply now