Shockwave zaps artery calcium for better stenting
NCT ID NCT06369142
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
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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
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About 666 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
19 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Asklepios Klinik Bad Oldesloe Innere Medizin, Kardiologie und Intensivmedizin
RECRUITINGBad Oldesloe, Schleswig-Holstein, 23843, Germany
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Augustinum Klinik München
RECRUITINGMünchen, Bavaria, 81375, Germany
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BG Klinikum Unfallkrankenhaus Berlin gGmbH
RECRUITINGBerlin, State of Berlin, 12683, Germany
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Cardiologikum Herzklinik Ulm MVZ
ACTIVE_NOT_RECRUITINGUlm, Baden-Wurttemberg, 89077, Germany
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Deutsches Herzzentrum München
RECRUITINGMunich, Bavaria, 80636, Germany
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Elisabeth Krankenhaus Essen Contilia Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie Kardiovaskuläres Studienzentrum
RECRUITINGEssen, North Rhine-Westphalia, 45138, Germany
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Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin)
RECRUITINGSingen, Baden-Wurttemberg, 78224, Germany
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Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie
RECRUITINGDachau, Bavaria, 85221, Germany
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Herz- und Diabeteszentrum Nordrhein-Westfalen
RECRUITINGBad Oeynhausen, North Rhine-Westphalia, 32545, Germany
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Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden
ACTIVE_NOT_RECRUITINGDresden, Saxony, 01307, Germany
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Klinik für Kardiologie, Angiologie und Intensivmedizin Deutsches Herzzentrum der Charité
RECRUITINGBerlin, State of Berlin, 10117, Germany
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Klinikum Hersfeld Rotenburg GmbH Herz-Kreislauf-Zentrum Institut für Klinische Forschung
RECRUITINGRotenburg an der Fulda, Hesse, 36199, Germany
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Klinikum Ingolstadt
RECRUITINGIngolstadt, Bavaria, 85049, Germany
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Klinikum Landkreis Erding
RECRUITINGErding, Bavaria, 85435, Germany
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Klinikum der Ludwig-Maximilians-Universität München
NOT_YET_RECRUITINGMünchen, Bavaria, 81337, Germany
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Krankenhaus Barmherzige Brüder Trier
RECRUITINGTrier, Rhineland-Palatinate, 54292, Germany
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Krankenhaus Landshut-Achdorf, LAKUMED Kliniken
RECRUITINGLandshut, Germany, 84036, Germany
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Universitäres Herz- und Gefäßzentrum
RECRUITINGHamburg, Free and Hanseatic City of Hamburg, 20246, Germany
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Universitätsklinikum Augsburg A.ö.R.
RECRUITINGAugsburg, Bavaria, 86156, Germany
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Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie
ACTIVE_NOT_RECRUITINGHeidelberg, Baden-Wurttemberg, 69120, Germany
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Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin
RECRUITINGMannheim, Baden-Wurttemberg, 68167, Germany
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Universitätsklinikum Ulm
RECRUITINGUlm, Baden-Wurttemberg, 89081, Germany
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Other studies related to the condition(s) this trial covers.
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- A soft patch that watches your heart beat in real time
- Zapping the ear: a new way to stop Post-Surgery heart rhythm problems?
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