Randomized Study Comparing ShockWAVE Coronary Lithotripsy and Other Techniques for Treating Severe Calcified Coronary Disease

What this Trial Is About

Researchers are evaluating the effectiveness, safety, and economic benefits of coronary lithotripsy compared to other lesion preparation methods like cutting or super high pressure balloon angioplasty and ablative procedures. The study focuses on treatment of severely calcified coronary artery stenoses in patients with coronary artery disease. It is a randomized, double-blind trial sponsored by Deutsches Herzzentrum Muenchen. Participants receive lesion preparation either by intravascular lithotripsy using balloons with a rated burst pressure of up to 18 atm or by other standard methods such as high, super high, cutting balloons, and ablative techniques. These procedures are performed before intracoronary stenting. The trial compares these approaches to assess additional benefits in treating severely calcified coronary lesions. During the study, participants are monitored for major cardiac and cerebrovascular events over 12 months after randomization. Researchers also track mortality, myocardial infarction, stroke, need for vessel revascularization, stent thrombosis, hospitalization for acute coronary syndrome, and bleeding events. Symptom assessments for physical and mental health related to coronary heart disease and medical costs are also evaluated. Safety and procedural success are closely observed throughout the study period.

Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy