Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy
Recruiting now · Not applicable
Conditions studied: Coronary Artery Disease
In brief
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.
Key facts
- Study ID
- NCT06369142
- Run by
- Deutsches Herzzentrum Muenchen
- People needed
- 666
- Starts
- 2024-07-01
- Expected to finish
- 2027-07-31
- Last updated by the study team
- 2026-01-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- myocardial infarction <1 week
- thrombus in the target vessel
- life expectancy due to other disease <1 year
- 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
Where it is running
- BG Klinikum Unfallkrankenhaus Berlin gGmbH — Berlin, State of Berlin, Germany (enrolling)
- Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin — Mannheim, Baden-Wurttemberg, Germany (enrolling)
- Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin) — Singen, Baden-Wurttemberg, Germany (enrolling)
- Elisabeth Krankenhaus Essen Contilia Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie Kardiovaskuläres Studienzentrum — Essen, North Rhine-Westphalia, Germany (enrolling)
- Krankenhaus Barmherzige Brüder Trier — Trier, Rhineland-Palatinate, Germany (enrolling)
- Asklepios Klinik Bad Oldesloe Innere Medizin, Kardiologie und Intensivmedizin — Bad Oldesloe, Schleswig-Holstein, Germany (enrolling)
- Klinik für Kardiologie, Angiologie und Intensivmedizin Deutsches Herzzentrum der Charité — Berlin, State of Berlin, Germany (enrolling)
- Universitätsklinikum Ulm — Ulm, Baden-Wurttemberg, Germany (enrolling)
- Universitätsklinikum Augsburg A.ö.R. — Augsburg, Bavaria, Germany (enrolling)
- Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie — Dachau, Bavaria, Germany (enrolling)
- Klinikum Landkreis Erding — Erding, Bavaria, Germany (enrolling)
- Klinikum Ingolstadt — Ingolstadt, Bavaria, Germany (enrolling)
- Deutsches Herzzentrum München — Munich, Bavaria, Germany (enrolling)
- Augustinum Klinik München — München, Bavaria, Germany (enrolling)
- Universitäres Herz- und Gefäßzentrum — Hamburg, Free and Hanseatic City of Hamburg, Germany (enrolling)
- Krankenhaus Landshut-Achdorf, LAKUMED Kliniken — Landshut, Germany, Germany (enrolling)
- Klinikum Hersfeld Rotenburg GmbH Herz-Kreislauf-Zentrum Institut für Klinische Forschung — Rotenburg an der Fulda, Hesse, Germany (enrolling)
- Herz- und Diabeteszentrum Nordrhein-Westfalen — Bad Oeynhausen, North Rhine-Westphalia, Germany (enrolling)
- Cardiologikum Herzklinik Ulm MVZ — Ulm, Baden-Wurttemberg, Germany
- Klinikum der Ludwig-Maximilians-Universität München — München, Bavaria, Germany
- Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie — Heidelberg, Baden-Wurttemberg, Germany
- Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden — Dresden, Saxony, Germany
Full record on ClinicalTrials.gov
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