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| Name | Class |
|---|---|
| Gemeinsamer Bundesaussschuss | OTHER |
| EvidentIQ Germany GmbH | UNKNOWN |
| Monitoring Services GmbH | UNKNOWN |
| Technical University of Munich |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lesion preparation using coronary intravascular lithotripsy | Experimental |
| |
| Lesion preparation using other methods than intravascular lithotripsy | Active Comparator | e.g. cutting or super high pressure balloons and/or ablative procedures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravascular lithotripsy (IVL) | Device | Intravascular lithotripsy (IVL) and ballons with a nominal rated burst pressure of ≤ 18 atm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined endpoint of major cardiac and cerebrovascular events | all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, clinically indicated revascularisation of the target vessel | 12 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 12 months after randomization | |
| Cardiac mortality | 12 months after randomization | |
| Non-fatal myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salvatore Cassese, MD, PHD | Contact | +49891218 | 2764 | cassese@dhm.mhn.de |
| Thorsten Kessler, MD | Contact | +49891218 | 2786 | thorsten.kessler@tum.de |
| Name | Affiliation | Role |
|---|---|---|
| Adnan Kastrati, MD | Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie | Active, not recruiting | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39710352 | Derived | Cassese S, Simonetti F, Covarrubias HAA, Janisch M, Joner M, Kufner S, Lenz T, Pellegrini C, Rheude T, Sager H, Schunkert H, Starnecker F, Voll F, Xhepa E, Kastrati A, Kessler T. Intracoronary stenting and additional results achieved by shockWAVE coronary lithotripsy: design and rationale of ISAR-WAVE trial. Am Heart J. 2025 Apr;282:1-12. doi: 10.1016/j.ahj.2024.12.008. Epub 2024 Dec 20. |
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| OTHER |
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The study participant as well as the follow-up physicians and site personal are blinded.
| Standard non-IVL methods | Device | Standard non-IVL methods treating severely calcified lesions such as special high, super high and cutting balloons and ablative procedures |
|
| 12 months after randomization |
| Non-fatal stroke | 12 months after randomization |
| Clinically indicated target vessel revascularization | 12 months after randomization |
| Definite stent thrombosis | 12 months after randomization |
| Clinically indicated non-target vessel revascularization | 12 months after randomization |
| Hospitalization due to acute coronary syndrome | 12 months after randomization |
| Symptoms of coronary heart disease (CHD): physical health status | 12 months after randomization |
| Symptoms of CHD: mental health status | 12 months after randomization |
| Bleeding during index hospitalization or ≤30 days (BARC 3-5) | 30 days after randomization |
| Procedural failure (failed application of study-related additional procedure, final TIMI flow <3, >30% residual stenosis, vessel perforation, stent loss, stent delivery failure) | 12 months after randomization |
| Medical costs (index hospitalization and costs for re-hospitalization due to acute coronary syndrome) | 12 months after randomization |
| Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin | Recruiting | Mannheim | Baden-Wurttemberg | 68167 | Germany |
|
| Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin) | Recruiting | Singen | Baden-Wurttemberg | 78224 | Germany |
|
| Cardiologikum Herzklinik Ulm MVZ | Active, not recruiting | Ulm | Baden-Wurttemberg | 89077 | Germany |
| Universitätsklinikum Ulm | Recruiting | Ulm | Baden-Wurttemberg | 89081 | Germany |
|
| Universitätsklinikum Augsburg A.ö.R. | Recruiting | Augsburg | Bavaria | 86156 | Germany |
|
| Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie | Recruiting | Dachau | Bavaria | 85221 | Germany |
|
| Klinikum Landkreis Erding | Recruiting | Erding | Bavaria | 85435 | Germany |
|
| Klinikum Ingolstadt | Recruiting | Ingolstadt | Bavaria | 85049 | Germany |
|
| Deutsches Herzzentrum München | Recruiting | Munich | Bavaria | 80636 | Germany |
|
| Klinikum der Ludwig-Maximilians-Universität München | Not yet recruiting | München | Bavaria | 81337 | Germany |
|
| Augustinum Klinik München | Recruiting | München | Bavaria | 81375 | Germany |
|
| Universitäres Herz- und Gefäßzentrum | Recruiting | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
|
| Krankenhaus Landshut-Achdorf, LAKUMED Kliniken | Recruiting | Landshut | Germany | 84036 | Germany |
|
| Klinikum Hersfeld Rotenburg GmbH Herz-Kreislauf-Zentrum Institut für Klinische Forschung | Recruiting | Rotenburg an der Fulda | Hesse | 36199 | Germany |
|
| Herz- und Diabeteszentrum Nordrhein-Westfalen | Recruiting | Bad Oeynhausen | North Rhine-Westphalia | 32545 | Germany |
|
| Elisabeth Krankenhaus Essen Contilia Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie Kardiovaskuläres Studienzentrum | Recruiting | Essen | North Rhine-Westphalia | 45138 | Germany |
|
| Krankenhaus Barmherzige Brüder Trier | Recruiting | Trier | Rhineland-Palatinate | 54292 | Germany |
|
| Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden | Active, not recruiting | Dresden | Saxony | 01307 | Germany |
| Asklepios Klinik Bad Oldesloe Innere Medizin, Kardiologie und Intensivmedizin | Recruiting | Bad Oldesloe | Schleswig-Holstein | 23843 | Germany |
|
| Klinik für Kardiologie, Angiologie und Intensivmedizin Deutsches Herzzentrum der Charité | Recruiting | Berlin | State of Berlin | 10117 | Germany |
|
| BG Klinikum Unfallkrankenhaus Berlin gGmbH | Recruiting | Berlin | State of Berlin | 12683 | Germany |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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