UnknownPhase 3

Arteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Intervention Clinical Trial

124 participantsStarted 2017-06

Plain-language summary

The purpose of this randomised clinical trial is to evaluate the efficacy of drug-eluting balloon compared to conventional balloon in balloon-assisted maturation of non-maturing arteriovenous fistula in adult renal failure patients.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. Non-maturing upper limb arteriovenous fistula (AVF) created 6-24 weeks ago with any one of the following:
✓. Non-maturing on physical examination, or
✓. Failed initial cannulation, or
✓. Failure to achieve prescribed dialysis within prescribed time frame.
✓. Stenosis (\>50%) along AVF circuit from anastomosis up to, but not including, the subclavian vein.
✓. Successful guidewire crossing of target lesion.
✓. \>= 21 years old.
✓. Informed consent given.

Exclusion criteria

✕. Thrombosed non-maturing AVF
✕. Target lesion is longer than 8 cm
✕. Previous endovascular therapy for non-maturation of the trial AVF
✕. Baseline systolic blood pressure less than 100 mmHg
✕. Non-maturing AVF is not planned to be used for dialysis in the immediate future (e.g. chronic kidney disease not requiring haemodialysis yet)
✕. Coagulopathy (prothrombin time or activated partial thromboplastin time \>1.5 times the median of normal range) that cannot be managed adequately with periprocedural transfusion
✕. Thrombocytopenia (platelet count \<50,000 /μL) that cannot be managed adequately with periprocedural transfusion
✕. Known allergy to iodinated contrast that cannot be managed adequately with pre-procedure medication

What they're measuring

Fistula used successfully for haemodialysis (FUSH)

Timeframe: 3 month

Trial details

NCT IDNCT03068845

SponsorSingapore General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06

Contact for this trial

Kun Da Zhuang, FRCR, MMed

+65 62223322 zhuang.kun.da@singhealth.com.sg

View on ClinicalTrials.gov More Stenosis of Arteriovenous Dialysis Fistula trials