Actively Recruiting
Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy
Led by Deutsches Herzzentrum Muenchen · Updated on 2026-01-06
666
Participants Needed
22
Research Sites
160 weeks
Total Duration
On this page
Sponsors
D
Deutsches Herzzentrum Muenchen
Lead Sponsor
G
Gemeinsamer Bundesaussschuss
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older 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 between 2.5 and 4 mm
- Severe calcification of the target lesion (angiographic grade 3)
You will not qualify if you...
- Myocardial infarction less than 1 week ago
- Thrombus in the target vessel
- Life expectancy less than 1 year due to other diseases
- Simultaneous participation in an ongoing clinical trial with medical devices or medicinal products
- Current, suspected, or planned pregnancy or positive pregnancy test
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie
Heidelberg, Baden-Wurttemberg, Germany, 69120
Active, Not Recruiting
2
Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin
Mannheim, Baden-Wurttemberg, Germany, 68167
Actively Recruiting
3
Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin)
Singen, Baden-Wurttemberg, Germany, 78224
Actively Recruiting
4
Cardiologikum Herzklinik Ulm MVZ
Ulm, Baden-Wurttemberg, Germany, 89077
Active, Not Recruiting
5
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany, 89081
Actively Recruiting
6
Universitätsklinikum Augsburg A.ö.R.
Augsburg, Bavaria, Germany, 86156
Actively Recruiting
7
Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie
Dachau, Bavaria, Germany, 85221
Actively Recruiting
8
Klinikum Landkreis Erding
Erding, Bavaria, Germany, 85435
Actively Recruiting
9
Klinikum Ingolstadt
Ingolstadt, Bavaria, Germany, 85049
Actively Recruiting
10
Deutsches Herzzentrum München
Munich, Bavaria, Germany, 80636
Actively Recruiting
11
Klinikum der Ludwig-Maximilians-Universität München
München, Bavaria, Germany, 81337
Not Yet Recruiting
12
Augustinum Klinik München
München, Bavaria, Germany, 81375
Actively Recruiting
13
Universitäres Herz- und Gefäßzentrum
Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246
Actively Recruiting
14
Krankenhaus Landshut-Achdorf, LAKUMED Kliniken
Landshut, Germany, Germany, 84036
Actively Recruiting
15
Klinikum Hersfeld Rotenburg GmbH Herz-Kreislauf-Zentrum Institut für Klinische Forschung
Rotenburg an der Fulda, Hesse, Germany, 36199
Actively Recruiting
16
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
Actively Recruiting
17
Elisabeth Krankenhaus Essen Contilia Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie Kardiovaskuläres Studienzentrum
Essen, North Rhine-Westphalia, Germany, 45138
Actively Recruiting
18
Krankenhaus Barmherzige Brüder Trier
Trier, Rhineland-Palatinate, Germany, 54292
Actively Recruiting
19
Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden
Dresden, Saxony, Germany, 01307
Active, Not Recruiting
20
Asklepios Klinik Bad Oldesloe Innere Medizin, Kardiologie und Intensivmedizin
Bad Oldesloe, Schleswig-Holstein, Germany, 23843
Actively Recruiting
21
Klinik für Kardiologie, Angiologie und Intensivmedizin Deutsches Herzzentrum der Charité
Berlin, State of Berlin, Germany, 10117
Actively Recruiting
22
BG Klinikum Unfallkrankenhaus Berlin gGmbH
Berlin, State of Berlin, Germany, 12683
Actively Recruiting
Research Team
S
Salvatore Cassese, MD, PHD
CONTACT
T
Thorsten Kessler, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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