Dysfunctional Dialysis Arteriovenous Fistula Clinical Trial
Official title:
Drug Coated Balloons vs Plain Balloons for the Management of Dysfunctional Dialysis Fistula
Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis arteriovenous fistulas (AVFs).
Objectives of the Study:
Hypothesis: Drug-coated balloons improve functional and patency outcomes of
failing/dysfunctional hemodialysis fistulas compared to plain uncoated balloons
Aim of the Study:
Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing
stenosis rates in dialysis AVFs.
Specific Objectives:
Primary functional endpoint: Access circuit patency based on functional criteria at 12 month.
Primary safety endpoint: Peri procedural complication rate
Secondary endpoints:
- Technical success (<30% residual stenosis without postdilation)
- Access circuit dysfunction free survival (Time to event) based on functional criteria
- Target lesion restenosis free survival (Time to event) (in case of new lesion causes
circuit dysfunction)
;