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Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis

ConditionsArteriovenous FistulaArteriovenous Fistula StenosisDialysis Access Malfunction
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age21+
SponsorSingapore General Hospital

About this trial

To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula (AVF) stenosis with that after conventional balloon angioplasty

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Failing AVF with at least 1 AVF stenosis presenting with any clinical, physiological or haemodynamic abnormalities. Both de novo and recurrent stenosis are accepted.

AVF has been used successfully for at least 1 month (non-mature AVF are not allowed).

Less than 30% residual stenosis after angioplasty.

≥ 21 years old

Disqualifiers

Thrombosed AVFs

Haemodynamically significant central vein stenosis

Target lesion not treatable with the available sizes of drug eluting balloon (up to 8mm)

Contraindication to antiplatelet therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Angioplasty of all peripheral AVF stenosis

    Device

    All peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: Drug-coated balloonExperimental treatment 1 intervention
Group B: Conventional balloonActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Access circuit primary patency

Time to next clinically-driven intervention

Time frame
6 months

Secondary outcomes

1

Access access circuit patency

Time to next clinically-driven intervention

Time frame
12 months
2

Access circuit assisted primary patency

Time to next access thrombosis or surgical intervention.

Time frame
6 and 12 months
3

Access circuit secondary patency

Time to access abandonment or surgical revision / declotting

Time frame
6 and 12 months
4

Procedural complication

Complication related to procedure

Time frame
12 months

Other outcomes

Sponsors and contacts

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

Singapore General Hospital

Lead sponsor

Singapore Clinical Research Institute

Collaborator

Boston Scientific Corporation

Collaborator

Source ClinicalTrials.gov
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