DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients W… (NCT07764016) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
142 participantsStarted 2026-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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/anticoagu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.