NCT06369142Recruiting
Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy
Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy: A Randomized, Multicenter Study About the Additional Benefit of Coronary Lithotripsy
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 666 (estimated)
- First submitted
- 12 Apr 2024
- Start date
- 1 Jul 2024
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Diseases
- Coronary artery disease
- NCT number
- NCT06369142
What you commit to
- Study type: Interventional
- Planned participants: 666
- From 1 Jul 2024 to the primary completion date, 30 Apr 2027
- 22 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- myocardial infarction \<1 week
- life expectancy due to other disease \<1 year
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinikum Augsburg A.ö.R Coordinator of this site? Confirm its status | Augsburg | Germany | Recruiting |
| Herz- und Diabeteszentrum Nordrhein-Westfalen Coordinator of this site? Confirm its status | Bad Oeynhausen | Germany | Recruiting |
| Asklepios Klinik Bad Oldesloe Innere Medizin, Kardiologie und Intensivmedizin Coordinator of this site? Confirm its status | Bad Oldesloe | Germany | Recruiting |
| Klinik für Kardiologie, Angiologie und Intensivmedizin Deutsches Herzzentrum der Charité Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| BG Klinikum Unfallkrankenhaus Berlin gGmbH Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie Coordinator of this site? Confirm its status | Dachau | Germany | Recruiting |
| Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Klinikum Landkreis Erding Coordinator of this site? Confirm its status | Erding | Germany | Recruiting |
| Elisabeth Krankenhaus Essen Contilia Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie Kardiovaskuläres Studienzentrum Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Universitäres Herz- und Gefäßzentrum Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie Coordinator of this site? Confirm its status | Heidelberg | Germany | Active, not recruiting |
| Klinikum Ingolstadt Coordinator of this site? Confirm its status | Ingolstadt | Germany | Recruiting |
| Krankenhaus Landshut-Achdorf, LAKUMED Kliniken Coordinator of this site? Confirm its status | Landshut | Germany | Recruiting |
| Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
| Augustinum Klinik München Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| Klinikum der Ludwig-Maximilians-Universität München Coordinator of this site? Confirm its status | München | Germany | Not yet recruiting |
| Deutsches Herzzentrum München Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Klinikum Hersfeld Rotenburg GmbH Herz-Kreislauf-Zentrum Institut für Klinische Forschung Coordinator of this site? Confirm its status | Rotenburg an der Fulda | Germany | Recruiting |
| Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin) Coordinator of this site? Confirm its status | Singen | Germany | Recruiting |
| Krankenhaus Barmherzige Brüder Trier Coordinator of this site? Confirm its status | Trier | Germany | Recruiting |
| Cardiologikum Herzklinik Ulm MVZ Coordinator of this site? Confirm its status | Ulm | Germany | Active, not recruiting |
| Universitätsklinikum Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.