Drug-coated Balloon Angioplasty After Non-Compliant Balloon Vessel Preparation With or Without Scoring for Femoropopliteal Arterial Disease: A Randomized Controlled Trial
The aim of this clinical trial is to determine whether vessel preparation with a non-compliant scoring balloon before drug-coated balloon (DCB) angioplasty provides superior procedural and clinical outcomes compared with vessel preparation using a non-compliant plain balloon in patients with chronic limb-threatening ischaemia (CLTI) undergoing femoropopliteal endovascular intervention. The main questions the study aims to answer are: * Does non-compliant scoring balloon vessel preparation reduce the need for bailout stenting during the index procedure? * Does it improve primary patency after DCB angioplasty? * Does it improve clinically relevant outcomes such as wound healing, freedom from clinically driven target lesion revascularisation, limb salvage and health-related quality of life? * Does it provide procedural and economic advantages compared with non-compliant plain balloon vessel preparation? Participants will be randomly assigned to undergo vessel preparation using either a non-compliant plain balloon or the DKutting™ non-compliant scoring balloon, followed by angioplasty with the Legflow XP™ drug-coated balloon. Patients will undergo clinical, duplex ultrasound and quality-of-life follow-up for 24 months.
The DASBAD-NC trial is a prospective, multicentre, randomised, patient-blinded, controlled clinical investigation designed to compare two vessel preparation strategies before drug-coated balloon (DCB) angioplasty for femoropopliteal arterial disease in patients with chronic limb-threatening ischaemia (Rutherford classification 4-5). Eligible patients with significant atherosclerotic femoropopliteal disease (≥50% stenosis or chronic total occlusion) will be randomised in a 1:1 ratio, after successful guidewire crossing of the target lesion and confirmation of all eligibility criteria, to one of two treatment strategies: * Vessel preparation using a non-compliant plain balloon (PBA arm), followed by Legflow 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 diameter ratio with a minimum inflation time of 180 seconds. Predilatation with a smaller balloon will 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 be permitted in the presence of residual stenosis ≥30% and/or flow-limiting dissection after DCB treatment. The co-primary endpoints are bailout stenting during the index procedure and primary patency at 12 months. Secondary endpoints include freedom from clinically driven target lesion revascularisation, target limb major amputation, all-cause mortality, wound healing, 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 an independent duplex ultrasound core laboratory. Procedural angiographic outcomes will undergo an independent blinded quality assurance review after database lock by experienced investigators according to the prespecified study methodology. Clinical events will be adjudicated by an independent Clinical Events Committee according to prespecified endpoint definitions. Patients will be followed for 24 months after the index procedure.
Inclusion Criteria: * ≥18 years of age. * Rutherford class 4-5. * Estimated life expectancy \>1 year, per investigator's judgment. * Significant atherosclerotic lesions (≥50% stenosis or chronic total occlusion) in the femoropopliteal segment, including in-stent restenosis. * Signed informed consent. * Willingness to comply with follow-up visits. * ≥1 patent infragenicular artery (\<50% stenosis) at the end of the procedure. * Target vessel diameter ≤8 mm.
Exclusion Criteria: * Pregnant or planning pregnancy during the study. * Participation in another drug/device trial. * Inability to cross the target lesion with a guidewire. Successful crossing is defined as advancement of the guidewire tip distal to the target lesion without vessel perforation or flow-limiting dissection. * Inadequate treatment of proximal lesion (\>30% residual stenosis). * Severe calcification of the target vessel \[group 4 of Fanelli classification17 defined as circumferential calcification (270º-360º)\], evidenced before contrast injection or digital subtraction angiography. * Thrombus in the target vessel. * Anastomotic stenosis of a bypass. * Use of atherectomy, thrombectomy, laser, or similar devices. * Prior or planned above-the-ankle amputation of the target limb. * Coagulopathy, hypercoagulable state, bleeding diathesis, platelets \<80 000/µL or \>700 000/µL, or other blood disorder. * Gastrointestinal bleeding requiring transfusion within 3 months. * Contraindication to antiplatelet/anticoagulant/thrombolytic therapy. * Acute coronary syndrome within 30 days. * Stroke or TIA within 90 days. * Hypersensitivity/contraindication to nitinol. * Comorbidities precluding treatment or follow-up (per investigator). * Hypersensitivity/allergy to contrast not manageable medically. * Hypersensitivity/allergy to heparin, aspirin, paclitaxel, clopidogrel, or other antiplatelet/anticoagulant agents. * Contraindication to dual antiplatelet therapy.
[{"measure":"Bailout stenting","timeFrame":"At index procedure"},{"measure":"Primary Patency","timeFrame":"At 12 months"}]