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Battle of the balloons: super High-Pressure vs shockwaves for Rock-Hard arteries

NCT ID NCT05072730

Disease control Sponsor: Deutsches Herzzentrum Muenchen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

80 people

The number who actually took part.

Started

Dec 2022

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age above 18 years and able to give consent * Persistent angina despite medical therapy and/or evidence of inducible ischemia * De-novo lesion in a native coronary artery * Target reference vessel diameter or intended stent diameter ≥2.50 or ≤4.00 mm by visual estimation * Severe calcification of the target lesion as determined by visual estimation at coronary angiography * Unsuccessful lesion preparation with standard non-compliant balloon (\< 30% reduction of baseline diameter stenosis at maximal pressure) * Written informed consent. Exclusion Criteria: * Target lesion is located in a coronary artery bypass graft * Target lesion is an in-stent restenosis * Target lesion is a chronic total occlusion * Target vessel thrombus * Limited long-term prognosis due to other comorbid conditions with life expectancy \<12 months

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary atherosclerosis

As listed by the trial registrant

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

Calcified coronary artery disease

Contacts and locations

Locations

  • Deutsches Herzzentrum Muenchen

    München, Germany

  • Helios Klinikum Erfurt

    Erfurt, 99089, Germany

  • Herz- und Diabeteszentrum NRW Universitätsklinikum der Ruhr-Universität Bochum

    Bad Oeynhausen, Germany

  • MEDICLIN Herzzentrum Lahr

    Lahr, 77933, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, Germany

  • Universitätsklinikum Jena

    Jena, 07747, Germany

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