Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Calcified lesion, Percutaneous Coronary Intervention, Stent, Intravascular Lithotripsy
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, ablative procedures) in lesion preparation and interventional treatment of severely calcified coronary stenoses.
Interventions
Intravascular lithotripsy (IVL) and ballons with a nominal rated burst pressure of ≤ 18 atm
DEVICEStandard non-IVL methods
Standard non-IVL methods treating severely calcified lesions such as special high, super high and cutting balloons and ablative procedures
Sponsors
Gemeinsamer Bundesaussschuss
EvidentIQ Germany GmbH
Monitoring Services GmbH
Technical University of Munich
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The study participant as well as the follow-up physicians and site personal are blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined endpoint of major cardiac and cerebrovascular events | 12 months after randomization | all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, clinically indicated revascularisation of the target vessel |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac mortality | 12 months after randomization |
| Non-fatal myocardial infarction | 12 months after randomization |
| Non-fatal stroke | 12 months after randomization |
| Clinically indicated target vessel revascularization | 12 months after randomization |
| Definite stent thrombosis | 12 months after randomization |
| Clinically indicated non-target vessel revascularization | 12 months after randomization |
| Mortality | 12 months after randomization |
| Symptoms of coronary heart disease (CHD): physical health status | 12 months after randomization |
| Symptoms of CHD: mental health status | 12 months after randomization |
| Bleeding during index hospitalization or ≤30 days (BARC 3-5) | 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) | 12 months after randomization |
| Medical costs (index hospitalization and costs for re-hospitalization due to acute coronary syndrome) | 12 months after randomization |
| Hospitalization due to acute coronary syndrome | 12 months after randomization |
Countries
Germany
Contacts
Primary ContactSalvatore Cassese, MD, PHD
Backup ContactThorsten Kessler, MD
Outcome results
None listed