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.
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
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
Parallel
Intravascular lithotripsy (IVL)
DeviceIntravascular lithotripsy (IVL) and ballons with a nominal rated burst pressure of ≤ 18 atm
Standard non-IVL methods
DeviceStandard non-IVL methods treating severely calcified lesions such as special high, super high and cutting balloons and ablative procedures
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
Mortality
Cardiac mortality
Non-fatal myocardial infarction
Non-fatal stroke
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Deutsches Herzzentrum Muenchen
Lead sponsor
Gemeinsamer Bundesaussschuss
Collaborator
EvidentIQ Germany GmbH
Collaborator
Monitoring Services GmbH
Collaborator
Technical University of Munich
Collaborator
