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

N/ANot Yet RecruitingNCT07764016

Marc Sirvent142 enrolled

Overview

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

Time frame: At index procedure

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.

Time frame: At 12 months

Secondary Outcomes

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.

Time frame: During the index procedure

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.

Time frame: 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.

Time frame: During the index procedure

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.

Time frame: During the index procedure

Procedural success

Procedural success, defined as technical success with absence of rupture, distal embolization, thrombosis, access complications, or major adverse cardiovascular events. These events should be listed as occurring \<24 hours and \<1 month of the procedure.

Time frame: Occurring <24 hours and <1 month of the index procedure.

Freedom from device and procedure-related death

Freedom from device and procedure-related death through 30 days post-procedure.

Time frame: Until 30 days post-procedure

Freedom from Major Adverse Events (MAE)

Freedom from Major Adverse Events (MAE) up to 24 months post-procedure. MAE are defined as the composite of: * Major Adverse Cardiovascular Events (MACE), including all-cause death, myocardial infarction, stroke, or major bleeding requiring transfusion or surgical intervention. * Major Adverse Limb Events (MALE), including above-the-ankle target limb amputation or major re-intervention involving the target lesion, defined as new bypass graft, jump/interposition graft revision, thrombectomy, thrombolysis or endovascular reintervention.

Time frame: Up to 24 months post-procedure

Primary patency

Primary patency at 6 and 24 months post-procedure, defined as absence of ≥50% restenosis (peak systolic velocity ratio\<2.5) and no CD-TLR, as adjudicated by the duplex core laboratory and the Clinical Events Committee (CEC).

Time frame: At 6 and 24 months post-procedure

Freedom from CD-TLR

Freedom from CD-TLR up to 24 months post-procedure. * CD-TLR is defined as any repeat revascularisation procedure performed to maintain or restore patency within the treated segment, including 5 mm proximal and 5 mm distal to the edges of the originally treated lesion, due to clinical deterioration. * Clinical deterioration is defined as a ≥1-category worsening in Rutherford classification, impaired wound healing, or new or recurrent ulceration or rest pain attributable to the target lesion

Time frame: Up to 24 months post-procedure

Change in Rutherford classification

Change in Rutherford classification up to 24 months post-procedure.

Time frame: Up to 24 months post-procedure.

Change in EQ-5D questionnaire

Change in EQ-5D questionnaire from baseline up to 24 months post-procedure

Time frame: Up to 24 months post-procedure

Amputation free survival

Amputation free survival up to 24 months post-procedure. • Amputation free survival is defined as survival without above-the-ankle amputation of the target limb.

Time frame: Up to 24 months post-procedure.

Wound healing evolution

Wound healing evolution up to 24 months post-procedure, assessed according to the following predefined ordinal classification: * Healed: Complete epithelialisation of the target wound maintained for at least 14 consecutive days. * Improved: Reduction in target wound area \>50% compared with baseline. * Unchanged: Increase or decrease in target wound area ≤50% compared with baseline. * Worsened: Increase in target wound area \>50% compared with baseline. The target wound will be defined as the largest or clinically most relevant wound identified at baseline.

Time frame: Up to 24 months post-procedure

Wound healing time

Wound healing time is defined as the number of days from the index procedure to complete epithelialisation of the target wound, without drainage or need for dressing, as assessed by the treating physician. • Major amputation of the index limb or death prior to complete wound healing will be considered failure of the wound healing endpoint.

Time frame: Days from the index procedure to complete epithelialisation of the target wound

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts