An interventional study of Non-compliant Plain Balloon angioplasty (PBA) and Non-compliant Scoring Balloon Angioplasty (SB) in Femoropopliteal Disease, Drug Coated Balloon and Critical Limb-Threatening Ischaemia, sponsored by Marc Sirvent. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Marc Sirvent · Not applicable, Interventional, and Treatment
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:
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 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.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 142 is above the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Marc Sirvent is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Vessel preparation using non-compliant plain balloon * Definitive treatment: drug-coated balloon angioplasty (Legflow XP™; Manufacturer: Cardionovum GmbH Bonn, Germany).
Device: Non-compliant Plain Balloon angioplasty (PBA)
* Vessel preparation using non-compliant scoring balloon (DKutting™; Manufacturer: DK Medical Technology Co., Ltd., Suzhou, China) * Definitive treatment: drug-coated balloon angioplasty (Legflow XP™; Manufacturer: Cardionovum GmbH Bonn, Germany) as definitve treatment.
Device: Non-compliant Scoring Balloon Angioplasty (SB)
The intervention consists of preparing the artery with a non-compliant plain balloon before using the DCB (Legflow XP™; Manufacturer: Cardionovum GmbH Bonn, Germany).
Also known as: Control group, Group 0
The 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.
Also known as: Treatment group, Intervention group, Group 1
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
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
No study locations are listed for this record.
Plan to share: No — Data collected within the DASBAD-NC study will be made available to researchers upon reasonable request. Access to the data is controlled to ensure the protection of participant privacy and compliance with applicable data protection laws and regulations. Data will be shared upon revision and approval based on scientific merit by the DASBAD-NC management group (which includes a qualified statistician) of a detailed proposal for their use. The data required for the approved, specified purposes and the trial protocol will be provided after the completion of a data-sharing agreement that will be set up by the principal investigator and his team. All data provided will be anonymized to respect the privacy of patients who have participated in the trial. Estimated timeframe for response will be within 30 days. Requests for data should be addressed to the sponsor and PI (msirvent@fphag.org).
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