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Shockwave zaps artery calcium for better stenting

NCT ID NCT06369142

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a new shockwave technique to standard balloon or cutting methods for preparing severely calcified heart arteries before placing a stent. About 666 adults with coronary artery disease will take part. The goal is to see if shockwave reduces major heart and brain events like heart attack or stroke.

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

About 666 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jul 2027

An estimate. End dates often move.

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: 1. age ≥18 years and able to give informed consent 2. written informed consent to participate in the clinical trial 3. typical angina pectoris or non-invasive evidence of relevant ischemia under optimal drug therapy 4. angiographic evidence of coronary artery disease 5. de novo lesion in a native coronary artery 6. target vessel diameter 2.5-4 mm 7. severe calcification of the target lesion (angiographic grade 3) Exclusion Criteria: 1. myocardial infarction \<1 week 2. thrombus in the target vessel 3. life expectancy due to other disease \<1 year 4. simultaneous participation in a clinical trial with medical devices or medicinal products that has not yet been completed 5. pregnancy (current, suspected, planned) or positive pregnancy test

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

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

Coronary artery disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asklepios Klinik Bad Oldesloe Innere Medizin, Kardiologie und Intensivmedizin

    RECRUITING

    Bad Oldesloe, Schleswig-Holstein, 23843, Germany

  • Augustinum Klinik München

    RECRUITING

    München, Bavaria, 81375, Germany

  • BG Klinikum Unfallkrankenhaus Berlin gGmbH

    RECRUITING

    Berlin, State of Berlin, 12683, Germany

  • Cardiologikum Herzklinik Ulm MVZ

    ACTIVE_NOT_RECRUITING

    Ulm, Baden-Wurttemberg, 89077, Germany

  • Deutsches Herzzentrum München

    RECRUITING

    Munich, Bavaria, 80636, Germany

  • Elisabeth Krankenhaus Essen Contilia Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie Kardiovaskuläres Studienzentrum

    RECRUITING

    Essen, North Rhine-Westphalia, 45138, Germany

  • Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin)

    RECRUITING

    Singen, Baden-Wurttemberg, 78224, Germany

  • Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie

    RECRUITING

    Dachau, Bavaria, 85221, Germany

  • Herz- und Diabeteszentrum Nordrhein-Westfalen

    RECRUITING

    Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

  • Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden

    ACTIVE_NOT_RECRUITING

    Dresden, Saxony, 01307, Germany

  • Klinik für Kardiologie, Angiologie und Intensivmedizin Deutsches Herzzentrum der Charité

    RECRUITING

    Berlin, State of Berlin, 10117, Germany

  • Klinikum Hersfeld Rotenburg GmbH Herz-Kreislauf-Zentrum Institut für Klinische Forschung

    RECRUITING

    Rotenburg an der Fulda, Hesse, 36199, Germany

  • Klinikum Ingolstadt

    RECRUITING

    Ingolstadt, Bavaria, 85049, Germany

  • Klinikum Landkreis Erding

    RECRUITING

    Erding, Bavaria, 85435, Germany

  • Klinikum der Ludwig-Maximilians-Universität München

    NOT_YET_RECRUITING

    München, Bavaria, 81337, Germany

  • Krankenhaus Barmherzige Brüder Trier

    RECRUITING

    Trier, Rhineland-Palatinate, 54292, Germany

  • Krankenhaus Landshut-Achdorf, LAKUMED Kliniken

    RECRUITING

    Landshut, Germany, 84036, Germany

  • Universitäres Herz- und Gefäßzentrum

    RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

  • Universitätsklinikum Augsburg A.ö.R.

    RECRUITING

    Augsburg, Bavaria, 86156, Germany

  • Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie

    ACTIVE_NOT_RECRUITING

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin

    RECRUITING

    Mannheim, Baden-Wurttemberg, 68167, Germany

  • Universitätsklinikum Ulm

    RECRUITING

    Ulm, Baden-Wurttemberg, 89081, Germany

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