Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
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
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
Treatments tested in this trial
- Angioplasty of all peripheral AVF stenosis
Treatment groups
94 Participants
are divided into 2 treatment groupsSponsors and collaborators
Singapore General Hospital
Lead sponsor
Singapore Clinical Research Institute
Collaborator
Boston Scientific Corporation
Collaborator
Source ClinicalTrials.gov