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.
≥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.
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).
Parallel
Non-compliant Plain Balloon angioplasty (PBA)
DeviceThe intervention consists of preparing the artery with a non-compliant plain balloon before using the DCB (Legflow XP™; Manufacturer: Cardionovum GmbH Bonn, Germany).
Non-compliant Scoring Balloon Angioplasty (SB)
DeviceThe intervention consists of preparing the artery with a non-compliant scoring balloon (DKutting™; Manufacturer: DK Medical Technology Co., Ltd., Suzhou, China) before using the DCB (Legflow XP™; Manufacturer: Cardionovum GmbH Bonn, Germany) as definitve treatment.
Bailout stenting
The need for bailout stenting during the index procedure, defined as stent implantation due to residual stenosis \>30% or a flow-limiting dissection (type C according to the Kobayashi classification)
Primary Patency
Primary patency at 12 months defined as absence of ≥50% restenosis (peak systolic velocity ratio\<2.5) and no clinically driven target lesion revascularisation (CD-TLR), as adjudicated by the duplex core laboratory and the Clinical Events Committee.
Device success
Device success, defined as successful delivery, inflation, and retrieval of the assigned balloon catheter, resulting in a residual stenosis \<30% without flow-limiting dissection (FLD) on final angiography.
Technical success
Technical success, defined as successful use of a device or technique to re-establish vessel patency with a residual stenosis \<30% by visual estimation and \<50% by duplex during the index procedure.
Procedural cost
Procedural cost, defined as the total acquisition cost (€) of all lesion preparation balloons (including adjunctive predilatation balloons, if required) and bailout stents used during the index procedure for the target lesion.
Slow-flow phenomenon
Slow-flow phenomenon, defined as an angiographic reduction in antegrade flow occurring after DCB inflation compared with the immediately preceding angiogram, in the absence of residual stenosis \>30%, flow-limiting dissection, or vasospasm. The presence or absence of slow-flow phenomenon will be determined by the independent blinded angiographic review.
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Marc Sirvent
Lead sponsor
Hospital de Granollers
Sponsor institution
DK Medical Technology (Suzhou) Co., Ltd.
Collaborator
Cardionovum GmbH
Collaborator
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