Tests shockwave lithotripsy during stent placement for calcified coronary artery narrowing
Compares shockwave treatment with standard methods to open hardened blockages in heart arteries.
Plain-language title generated from the registry record
Registry title: Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy
Key facts
- Where
- Augsburg, Bad Oeynhausen, Bad Oldesloe, Berlin, Dachau, Dresden, Erding, Essen, Hamburg, Heidelberg, Ingolstadt, Landshut, Mannheim, München, Munich, Rotenburg an der Fulda, Singen, Trier, and Ulm, GermanySee the 22 sites
Where in Germany
- Universitätsklinikum Augsburg A.ö.RAugsburg, GermanyTaking people
- Herz- und Diabeteszentrum Nordrhein-WestfalenBad Oeynhausen, GermanyTaking people
- Asklepios Klinik Bad Oldesloe Innere Medizin, Kardiologie und IntensivmedizinBad Oldesloe, GermanyTaking people
- BG Klinikum Unfallkrankenhaus Berlin gGmbHBerlin, GermanyTaking people
- Klinik für Kardiologie, Angiologie und Intensivmedizin Deutsches Herzzentrum der CharitéBerlin, GermanyTaking people
- Helios Amper-Klinikum Dachau, Kardiologie und PneumologieDachau, GermanyTaking people
- Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität DresdenDresden, GermanyNo longer taking part
- Klinikum Landkreis ErdingErding, GermanyTaking people
- Elisabeth Krankenhaus Essen Contilia Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie Kardiovaskuläres StudienzentrumEssen, GermanyTaking people
- Universitäres Herz- und GefäßzentrumHamburg, GermanyTaking people
- Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und PneumologieHeidelberg, GermanyNo longer taking part
- Klinikum IngolstadtIngolstadt, GermanyTaking people
- Krankenhaus Landshut-Achdorf, LAKUMED KlinikenLandshut, GermanyTaking people
- Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische IntensivmedizinMannheim, GermanyTaking people
- Augustinum Klinik MünchenMünchen, GermanyTaking people
- Klinikum der Ludwig-Maximilians-Universität MünchenMünchen, GermanyNot yet recruiting
- Deutsches Herzzentrum MünchenMunich, GermanyTaking people
- Klinikum Hersfeld Rotenburg GmbH Herz-Kreislauf-Zentrum Institut für Klinische ForschungRotenburg an der Fulda, GermanyTaking people
- Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin)Singen, GermanyTaking people
- Krankenhaus Barmherzige Brüder TrierTrier, GermanyTaking people
- Universitätsklinikum UlmUlm, GermanyTaking people
- Cardiologikum Herzklinik Ulm MVZUlm, GermanyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Deutsches Herzzentrum Muenchen
- Trial code
- NCT06369142
- Record updated
- 6 January 2026
- Original description
The clinical trial is intended to evaluate the efficacy, safety and economic benefit of coronary lithotripsy compared to other additional procedures (cutting or super high pressure balloon angioplasty, ablative procedures) in lesion preparation and interventional treatment of severely calcified coronary stenoses.Read full original descriptionShow less
Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy: A Randomized, Multicenter Study About the Additional Benefit of Coronary Lithotripsy
The clinical trial is intended to evaluate the efficacy, safety and economic benefit of coronary lithotripsy compared to other additional procedures (cutting or super high pressure balloon angioplasty, ablative procedures) in lesion preparation and interventional treatment of severely calcified coronary stenoses.
Inclusion: age ≥18 years and able to give informed consent; written informed consent to participate in the clinical trial; typical angina pectoris or non-invasive evidence of relevant ischemia under optimal drug therapy; angiographic evidence of coronary artery disease; de novo lesion in a native coronary artery; target vessel diameter 2.5-4 mm; severe calcification of the target lesion (angiographic grade 3).
Exclusion: myocardial infarction <1 week; life expectancy due to other disease <1 year; thrombus in the target vessel; simultaneous participation in a clinical trial with medical devices or medicinal products that has not yet been completed; pregnancy (current, suspected, planned) or positive pregnancy test.