Vascular Access Complication Clinical Trial
Official title:
A Randomized Trial of Aperto Paclitaxel Eluting Dilatation Catheter Compared to POBA in Dialysis Fistula
A multicenter randomized clinical trial of paclitaxel drug-eluting balloon (DEB) versus standard percutaneous transluminal angioplasty (PTA) to reduce restenosis in 150 patients with haemodialysis access stenoses.
Prospective multicenter randomized (1:1) Investigator Sponsored Trial, in which 150
consecutive patients candidates for percutaneous intervention of haemodialysis access will be
randomly assigned to one of two study arms:
1. Treatment Arm: paclitaxel drug-eluting balloon (DEB) dilatation using the APERTO-balloon
2. Control Arm: standard percutaneous transluminal angioplasty (PTA).
The aim is to evaluate the safety and efficacy of paclitaxel drug-eluting balloon (DEB) for
the reduction of restenosis in haemodialysis shunts compared to standard percutaneous
transluminal angioplasty (PTA).
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