Battle of the balloons: super High-Pressure vs shockwaves for Rock-Hard arteries
NCT ID NCT05072730
First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time
Summary
This trial tests two techniques for treating severely calcified coronary arteries before placing a stent. One uses a super high-pressure balloon to crack the calcium; the other uses intravascular lithotripsy, which sends shockwaves through the artery wall. The study includes 80 adults with hard-to-treat blockages and measures how wide the artery becomes after preparation. The goal is to see which method leads to better stent placement and fewer complications.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Super high-pressure balloon (OPN NC) and intravascular lithotripsy (IVL)
- What this could lead to
- If one method proves better, it could improve stent placement success and reduce complications in people with heavily calcified heart arteries.
- What could go wrong
- This is a small, early-stage trial with only 80 participants, so results may not apply to all patients. Both techniques carry risks like vessel injury or incomplete expansion.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Deutsches Herzzentrum Muenchen
München, Germany
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Helios Klinikum Erfurt
Erfurt, 99089, Germany
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Herz- und Diabeteszentrum NRW Universitätsklinikum der Ruhr-Universität Bochum
Bad Oeynhausen, Germany
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MEDICLIN Herzzentrum Lahr
Lahr, 77933, Germany
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Universitätsklinikum Frankfurt
Frankfurt am Main, Germany
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Universitätsklinikum Jena
Jena, 07747, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New device uses sound waves to crack heart artery calcium
- Sound wave device aims to improve heart stent success in women
- Heart artery showdown: shockwave or cutting balloon before stenting?
- CT scans could make heart stent surgery safer and faster
- Shockwaves in your heart: new device zaps artery calcium
- Shockwave therapy could crack tough heart blockages