RecruitingPhase 3NCT06553443
Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
Sponsor
Singapore General Hospital
Enrollment
94 participants
Start Date
Jan 4, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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
Min Age: 21 Years
Inclusion Criteria5
- 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 Criteria10
- 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.
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Interventions
DEVICEAngioplasty of all peripheral AVF stenosis
All peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06553443
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