An interventional study of Intravascular lithotripsy (IVL) and Standard non-IVL methods in Coronary Artery Disease, sponsored by Deutsches Herzzentrum Muenchen. Recruiting at 22 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Deutsches Herzzentrum Muenchen · Not applicable, Interventional, and Treatment
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 666 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Deutsches Herzzentrum Muenchen is the lead sponsor of 114 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Intravascular lithotripsy (IVL)
e.g. cutting or super high pressure balloons and/or ablative procedures
Device: Standard non-IVL methods
Intravascular lithotripsy (IVL) and ballons with a nominal rated burst pressure of ≤ 18 atm
Standard 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
Time frame: 12 months after randomization
Mortality
Time frame: 12 months after randomization
Cardiac mortality
Time frame: 12 months after randomization
Non-fatal myocardial infarction
Time frame: 12 months after randomization
Non-fatal stroke
Time frame: 12 months after randomization
Clinically indicated target vessel revascularization
Time frame: 12 months after randomization
Definite stent thrombosis
Time frame: 12 months after randomization
Clinically indicated non-target vessel revascularization
Time frame: 12 months after randomization
Hospitalization due to acute coronary syndrome
Time frame: 12 months after randomization
Symptoms of coronary heart disease (CHD): physical health status
Time frame: 12 months after randomization
Symptoms of CHD: mental health status
Time frame: 12 months after randomization
Bleeding during index hospitalization or ≤30 days (BARC 3-5)
Time frame: 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)
Time frame: 12 months after randomization
Medical costs (index hospitalization and costs for re-hospitalization due to acute coronary syndrome)
Time frame: 12 months after randomization
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Plan to share: No
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