Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy

Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy: A Randomized, Multicenter Study About the Additional Benefit of Coronary Lithotripsy

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.

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