Using ShockWAVE technology to treat severely calcified coronary artery disease
Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy: A Randomized, Multicenter Study About the Additional Benefit of Coronary Lithotripsy
NA · Deutsches Herzzentrum Muenchen · NCT06369142
This study is testing a new technology called ShockWAVE to see if it can help people with severely calcified coronary artery disease get better results from stenting compared to standard methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 666 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Deutsches Herzzentrum Muenchen (other) |
| Locations | 22 sites (Heidelberg, Baden-Wurttemberg and 21 other locations) |
| Trial ID | NCT06369142 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of intravascular lithotripsy (IVL) compared to traditional methods for preparing severely calcified coronary lesions before stenting. The study focuses on patients with significant coronary artery disease who have not responded adequately to optimal drug therapy. Participants will undergo procedures to assess the effectiveness of IVL in improving outcomes related to coronary interventions. The trial aims to provide insights into the economic benefits of using IVL in clinical practice.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe calcification in coronary lesions and evidence of ischemia.
Not a fit: Patients with recent myocardial infarction, significant thrombus in the target vessel, or limited life expectancy due to other diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with severely calcified coronary artery disease.
How similar studies have performed: Other studies have shown promising results with similar lithotripsy techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Heidelberg, Baden-Wurttemberg and 21 other locations
- Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie — Heidelberg, Baden-Wurttemberg, Germany (ACTIVE_NOT_RECRUITING)
- Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin — Mannheim, Baden-Wurttemberg, Germany (RECRUITING)
- Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin) — Singen, Baden-Wurttemberg, Germany (RECRUITING)
- Cardiologikum Herzklinik Ulm MVZ — Ulm, Baden-Wurttemberg, Germany (ACTIVE_NOT_RECRUITING)
- Universitätsklinikum Ulm — Ulm, Baden-Wurttemberg, Germany (RECRUITING)
- Universitätsklinikum Augsburg A.ö.R. — Augsburg, Bavaria, Germany (RECRUITING)
- Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie — Dachau, Bavaria, Germany (RECRUITING)
- Klinikum Landkreis Erding — Erding, Bavaria, Germany (RECRUITING)
- Klinikum Ingolstadt — Ingolstadt, Bavaria, Germany (RECRUITING)
- Deutsches Herzzentrum München — Munich, Bavaria, Germany (RECRUITING)
- Klinikum der Ludwig-Maximilians-Universität München — München, Bavaria, Germany (NOT_YET_RECRUITING)
- Augustinum Klinik München — München, Bavaria, Germany (RECRUITING)
- Universitäres Herz- und Gefäßzentrum — Hamburg, Free and Hanseatic City of Hamburg, Germany (RECRUITING)
- Krankenhaus Landshut-Achdorf, LAKUMED Kliniken — Landshut, Germany, Germany (RECRUITING)
- Klinikum Hersfeld Rotenburg GmbH Herz-Kreislauf-Zentrum Institut für Klinische Forschung — Rotenburg an der Fulda, Hesse, Germany (RECRUITING)
- Herz- und Diabeteszentrum Nordrhein-Westfalen — Bad Oeynhausen, North Rhine-Westphalia, Germany (RECRUITING)
- Elisabeth Krankenhaus Essen Contilia Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie Kardiovaskuläres Studienzentrum — Essen, North Rhine-Westphalia, Germany (RECRUITING)
- Krankenhaus Barmherzige Brüder Trier — Trier, Rhineland-Palatinate, Germany (RECRUITING)
- Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden — Dresden, Saxony, Germany (ACTIVE_NOT_RECRUITING)
- Asklepios Klinik Bad Oldesloe Innere Medizin, Kardiologie und Intensivmedizin — Bad Oldesloe, Schleswig-Holstein, Germany (RECRUITING)
- Klinik für Kardiologie, Angiologie und Intensivmedizin Deutsches Herzzentrum der Charité — Berlin, State of Berlin, Germany (RECRUITING)
- BG Klinikum Unfallkrankenhaus Berlin gGmbH — Berlin, State of Berlin, Germany (RECRUITING)
Study contacts
- Study coordinator: Salvatore Cassese, MD, PHD
- Email: cassese@dhm.mhn.de
- Phone: +49891218
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease, Calcified lesion, Percutaneous Coronary Intervention, Stent, Intravascular Lithotripsy