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โ† Trials
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Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis

RecruitingPhase 3Ages 21 Years - anyAllSingapore General Hospital
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Failing AVF with at least 1 AVF stenosis presenting with any clinical, physiological or haemodynamic abnormalities. Both de novo and recurrent stenosis are accepted. 2. AVF has been used successfully for at least 1 month (non-mature AVF are not allowed). 3. Less than 30% residual stenosis after angioplasty. 4. โ‰ฅ 21 years old 5. Informed and valid consent given. Exclusion Criteria: 1. Thrombosed AVFs 2. Haemodynamically significant central vein stenosis 3. Target lesion not treatable with the available sizes of drug eluting balloon (up to 8mm) 4. Contraindication to antiplatelet therapy 5. Coagulopathy or thrombocytopenia that cannot be managed adequately with periprocedural transfusion. 6. Allergy / contraindication to paclitaxel. 7. Acute infection over proposed puncture site. 8. Women who are breastfeeding, pregnant \* or planning on becoming pregnant during study. 9. Participant with medical conditions, which in the opinion of the investigator may cause noncompliance with protocol. 10. 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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What it tests

  • Angioplasty of all peripheral AVF stenosis
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Where

1 site
Singapore General Hospital
Singapore, Singapore
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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