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

NCT07764016 | Not Yet Recruiting

• 1 other identifier: DASBAD-NC
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Femoropopliteal Disease; Drug Coated Balloon; Critical Limb-Threatening Ischaemia; Peripheral Arterial Disease

Keywords

Chronic Limb-Threatening Ischaemia (CLTI); Peripheral Artery Disease (PAD); Femoropopliteal Disease; Drug-Coated Balloon (DCB); Vessel Preparation; Scoring Balloon; Non-Compliant Balloon; Primary Patency; Bailout Stenting

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  At 12 months

Secondary Outcomes (14)

• Device success

  During the index procedure

• Technical success

  During the index procedure.

• Procedural cost

  During the index procedure

• Slow-flow phenomenon

  During the index procedure

• Procedural success

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

Study Arms (2)

Non-compliant plain balloon (PBA)

ACTIVE COMPARATOR

* 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)

Scoring balloon (SB)

ACTIVE COMPARATOR

* 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)

Interventions

Non-compliant Plain Balloon angioplasty (PBA) DEVICE

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

Non-compliant plain balloon (PBA)

Non-compliant Scoring Balloon Angioplasty (SB) DEVICE

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

Scoring balloon (SB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marc Sirvent: lead
• DK Medical Technology (Suzhou) Co., Ltd.: collaborator
• Cardionovum GmbH: collaborator

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Marc Sirvent, PhD

CONTACT

+34938425000; msirvent@fphag.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will remain blinded to treatment allocation. Treating physicians and investigators responsible for the index procedure cannot be blinded because of the nature of the intervention. Duplex ultrasound follow-up examinations will undergo blinded central review by an independent core laboratory. Clinical events will be adjudicated by an independent Clinical Events Committee blinded to treatment allocation. Procedural angiographic outcomes will undergo an independent blinded quality assurance review after database lock. Statistical analyses will be performed by an independent statistician blinded to treatment allocation until completion of the primary analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, MD, FEBVS, Head of the Department of Angiology and Vascular Surgery, Hospital General de Granollers

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share