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 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.