Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Angioplasty of all peripheral AVF stenosis.
- Who it may be relevant to
- Registry conditions: Arteriovenous Fistula, Arteriovenous Fistula Stenosis, Dialysis Access Malfunction. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula (AVF) stenosis with that after conventional balloon angioplasty
Detailed description
This is a blinded randomized controlled trial recruiting 94 patients with AVF stenosis who will be randomized in a 1:1 ratio to either drug-coated balloon (Ranger) or conventional balloon. All peripheral AVF stenoses will be treated with the allocated balloon type.
The primary outcome measure is 6-month access circuit patency.
Interventions
- Device Angioplasty of all peripheral AVF stenosis
All peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation
Primary outcome measures
- Access circuit primary patency [Time frame: 6 months]
Secondary outcome measures (5)
- Access access circuit patency [Time frame: 12 months]
- Access circuit assisted primary patency [Time frame: 6 and 12 months]
- Access circuit secondary patency [Time frame: 6 and 12 months]
- Procedural complication [Time frame: 12 months]
- Mortality [Time frame: 12 months and 5 years]
Eligibility criteria
Inclusion criteria
- 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
- Informed and valid consent given.
Exclusion criteria
- 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
- Coagulopathy or thrombocytopenia that cannot be managed adequately with periprocedural transfusion.
- Allergy / contraindication to paclitaxel.
- Acute infection over proposed puncture site.
- Women who are breastfeeding, pregnant \* or planning on becoming pregnant during study.
- Participant with medical conditions, which in the opinion of the investigator may cause noncompliance with protocol.
- Currently participating in an investigational drug, biologic or device trial that may have an impact on the dialysis access or previous enrolment in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Singapore · 1 center
- Singapore General Hospital — Singapore
Identifiers
NCT: NCT06553443 · RANGER