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

Launched by FRENCH CARDIOLOGY SOCIETY · Oct 28, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the C2 Shockwave Medical Coronary Lithotripsy System, which is designed to help treat hard, calcified plaque in the arteries before a procedure called coronary angioplasty. This new technology aims to make it easier for doctors to place stents—tiny tubes that help keep arteries open—by breaking up the tough plaque that can block blood flow. The trial is important because calcified lesions can lead to complications during procedures and are becoming more common, especially among people with diabetes.

To be eligible for this trial, participants must be at least 18 years old and covered by France's National Health Insurance. They also need to be undergoing angioplasty using this specific Shockwave device due to certain conditions related to stent placement. If someone joins the study, they can expect to contribute valuable information about the safety and effectiveness of this new technology while receiving care for their heart condition. It's important to note that pregnant or breastfeeding individuals, as well as those unable to give consent, cannot participate in the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient over 18 years old
• • Patient affiliated to the National Health Insurance System
• • Patient for whom a coronary angioplasty procedure is performed using the Shockwave Medical C2 Coronary Lithotripsy System
• • For indications of stent malexpansions, stent malexpansion must be defined by: a) angiography: stent malexpansion \>30% (QCA and/or stent magnification) b) endocoronary OCT/IVUS imaging with MSA (Minimal Stent Area) \<4.5 mm2 or a ratio of MSA/MLA on reference segment\<0.8
• • Patient willing to participate in the registry
• Exclusion Criteria:
• • Patient under 18 years of age
• • Pregnant or breastfeeding patient
• • Patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or legal guardianship)