Can a 'Scoring' balloon unclog leg arteries better and reduce stents?

NCT ID NCT07764016

Not yet recruiting Disease control Sponsor: Marc Sirvent Source: ClinicalTrials.gov ↗

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial is testing whether preparing a blocked leg artery with a special 'scoring' balloon before using a drug-coated balloon improves outcomes compared to using a standard balloon. The study involves people with severe leg artery disease (critical limb-threatening ischemia) who need a procedure to restore blood flow. Participants are randomly assigned to one of two balloon preparation methods, and researchers will track how well the artery stays open, whether stents are needed, wound healing, and quality of life over two years.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Drug-coated balloon angioplasty with a non-compliant scoring balloon (DKutting) versus a non-compliant plain balloon, followed by a drug-coated balloon (Legflow XP).
What this could lead to: If the scoring balloon works better, it could reduce the need for stents and improve long-term blood flow in the legs, potentially saving limbs and improving quality of life for people with severe peripheral artery disease.
What could go wrong: This is a randomized trial, but the outcome depends on many factors, including the severity of disease and individual healing. The scoring balloon may not significantly outperform the standard approach, and there are risks of complications like vessel injury or restenosis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Chronic Limb-Threatening Ischemia peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CRITICAL LIMB-THREATENING ISCHAEMIA DRUG COATED BALLOON FEMOROPOPLITEAL DISEASE PERIPHERAL ARTERIAL DISEASE

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