Status:
RECRUITING
Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Collaborating Sponsors:
Gemeinsamer Bundesaussschuss
EvidentIQ Germany GmbH
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
666 Patients enrolled
Trial Details
Trial ID
NCT06369142
Start Date
July 1 2024
End Date
July 31 2027
Last Update
January 6 2026
Active Locations (22)
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1
Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie
Heidelberg, Baden-Wurttemberg, Germany, 69120
2
Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin
Mannheim, Baden-Wurttemberg, Germany, 68167
3
Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin)
Singen, Baden-Wurttemberg, Germany, 78224
4
Cardiologikum Herzklinik Ulm MVZ
Ulm, Baden-Wurttemberg, Germany, 89077