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

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.

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 (\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 \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.