DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease

The DASBAD‐NC trial is a prospective, multicentre, randomised, patient‐blinded,controlled clinical investigation designed to compare two vessel preparation strategiesbefore drug‐coated balloon (DCB) angioplasty for femoropopliteal arterial disease inpatients with chronic limb‐threatening ischaemia (Rutherford classification 4‐5).Eligible patients with significant atherosclerotic femoropopliteal disease (≥50% stenosisor chronic total occlusion) will be randomised in a 1:1 ratio, after successful guidewirecrossing of the target lesion and confirmation of all eligibility criteria, to one of twotreatment strategies: ‐ Vessel preparation using a non‐compliant plain balloon (PBA arm), followed byLegflow XP™ drug‐coated balloon angioplasty. ‐ Vessel preparation using the DKutting™ non‐compliant scoring balloon (SB arm),followed by Legflow XP™ drug‐coated balloon angioplasty.Vessel preparation will be performed using a 1:1 balloon‐to‐reference vessel diameterratio with a minimum inflation time of 180 seconds. Predilatation with a smaller balloonwill only be permitted if the allocated study balloon cannot cross the lesion.Drug‐coated balloon angioplasty will subsequently be performed using the Legflow XP™drug‐coated balloon according to the study protocol. Bailout stenting will only bepermitted in the presence of residual stenosis ≥30% and/or flow‐limiting dissection afterDCB treatment.The co‐primary endpoints are bailout stenting during the index procedure and primarypatency at 12 months. Secondary endpoints include freedom from clinically driven targetlesion revascularisation, target limb major amputation, all‐cause mortality, woundhealing, health‐related quality of life, procedural success, slow‐flow phenomenon,procedural costs and other prespecified clinical and imaging outcomes.Duplex ultrasound follow‐up examinations will undergo blinded central review by anindependent duplex ultrasound core laboratory. Procedural angiographic outcomes willundergo an independent blinded quality assurance review after database lock byexperienced investigators according to the prespecified study methodology. Clinicalevents will be adjudicated by an independent Clinical Events Committee according toprespecified endpoint definitions.Patients will be followed for 24 months after the index procedure.