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This is the first AVF randomised controlled study to archive statistical superiority of a high pressure DCB versus high-pressure plain balloon angioplasty. In a population of 161 patients, treatment with the device achieved superiority in freedom from restenosis at six months, and better intervention-free survival of both the target lesion and target shunt at 12 months with equivalent safety. Additionally, patients treated with APERTO maintained patency for another three months.

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