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

Sponsor
Marc Sirvent
Study ID
NCT07764016
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).
  • 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.

Study Details

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.

Key Dates

First listed
Aug 13, 2026
Start date
Dec 31, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
142 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Non-compliant plain balloon (PBA)
    * Vessel preparation using non-compliant plain balloon * Definitive treatment: drug-coated balloon angioplasty (Legflow XP™; Manufacturer: Cardionovum GmbH Bonn, Germany).
  • Active Comparator: Scoring balloon (SB)
    * 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.

Primary Outcome Measure

Bailout stenting [ Time Frame: At index procedure ]

Central Contacts

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