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Compares treatment options for Arteriovenous Fistula
Official title Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
ClinicalTrials.gov ID: NCT06553443
What this study is testing
- What it's testing
- To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula (AVF) stenosis with that after conventional balloon angioplasty
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Failing AVF with at least 1 AVF stenosis presenting with any clinical, physiological or haemodynamic abnormalities. Both de novo and recurrent...
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.