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

NCT07764016 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2026-08-14

No results posted yet for this study

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

Interventions

DEVICE

Non-compliant Plain Balloon angioplasty (PBA)

The intervention consists of preparing the artery with a non-compliant plain balloon before using the DCB (Legflow XP™; Manufacturer: Cardionovum GmbH Bonn, Germany).

DEVICE

Non-compliant Scoring Balloon Angioplasty (SB)

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.

Sponsors & Collaborators

  • DK Medical Technology (Suzhou) Co., Ltd.

    collaborator INDUSTRY

  • Cardionovum GmbH

    collaborator INDUSTRY

  • Marc Sirvent

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2029-12-31
Completion
2030-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07764016 on ClinicalTrials.gov