Observatory on the Use of the Shockwave Medical C2 Coronary Lithotripsy System in the General Population in France

What this Trial Is About

Researchers are studying the use of the Shockwave Medical C2 Coronary Lithotripsy System (IVL) for coronary angioplasty in patients with calcified coronary lesions in France. These calcified lesions are increasingly common, especially due to factors like diabetes, and are linked to complications and poorer clinical outcomes. Traditional plaque preparation techniques such as rotary atherectomy are not widely used in France and have uncertain effectiveness and higher complication rates. This study aims to evaluate the safety and performance of this new lithotripsy device in routine clinical practice across the general population. The study observes coronary angioplasty procedures where the C2 Coronary Lithotripsy System is used to create microfractures in calcified plaques, which helps in balloon dilatation and stent delivery. The registry includes patients undergoing this treatment and monitors the device's success and procedural outcomes during initial hospitalization. Follow-up assessments continue for one year after the procedure to evaluate clinical events such as major adverse cardiac events, stent thrombosis, and target lesion failure. Participants will be monitored during their hospital stay and followed for one year after their angioplasty procedure. Data collected includes procedural success, device performance, and any complications during hospitalization and follow-up. Researchers will also review safety and effectiveness outcomes one year post-procedure. Participation involves agreeing to be part of the registry and allowing data collection related to the procedure and follow-up care.

Observatory on the Use of the Shockwave Medical C2 Coronary Lithotripsy System in the General Population in France.