New Shockwave-Stent combo tackles tough leg artery blockages

NCT ID NCT05291247

Completed Disease control Sponsor: Marc Bosiers, MD Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study tested a two-step treatment for severely calcified leg artery disease in 50 patients. First, a shockwave device cracks the hard calcium deposits, then a drug-coated stent is placed to keep the artery open. The goal was to see if this approach is safe and effective at maintaining blood flow for 12 months.

What this could mean

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

Active substance: Shockwave intravascular lithotripsy device and a drug-eluting vascular stent
What this could lead to: If successful, this combination could offer a safer, more effective way to open severely calcified leg arteries, reducing the need for repeat procedures.
What could go wrong: This is a small, completed trial with 50 participants, so results may not apply to everyone. The procedure carries risks like vessel rupture, blood clots, or heart complications.

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.

calcinosis peripheral arterial disease Vascular Calcification

As listed by the trial registrant

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

CALCIFICATIONS VASCULAR PERIPHERAL ARTERIAL DISEASE SUPERFICIAL FEMORAL ARTERY STENOSIS

Contacts and locations

Locations

Klinikum Hochsauerland

Arnsberg, North Rhine-Westphalia, 59759, Germany
SRH Klinikum Karlsbad-Langensteinbach

Baden-Baden, Baden-Wurttemberg, 76307, Germany
St. Marien Hospital Lünen

Lünen, North Rhine-Westphalia, 44534, Germany
University Hospital Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany
University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany
University Hospital LMU Munich

Munich, Bavaria, 80337, Germany

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