France LILI (LIthopLastie Intracoronaire)

Abstract

BackgroundIntravascular lithotripsy (IVL) is a novel and appealing device for the preparation of coronary calcified lesions before stenting. This technology has received CE mark and FDA approval, according to the data of the CAD studies. However, these clinical trials show numerous limits as the exclusion of a subset of lesions (Left main, CTO, in stent restenosis …) and patients’ over-selection. In this view, applications of IVL results in daily practice are debatable according to the lack of evidence in unselected patients. MethodsFRANCE-LILI is a prospective national academic registry evaluating the safety and effectiveness of adjunctive intravascular lithotripsy in coronary angioplasty in an all-comers patient population in France. The registry is registered with the ClinicalTrials.gov database (NCT05113407) and managed by the French Coronary Atheroma and Interventional Cardiology Group (GACI) of the French Society of Cardiology (FSC).France LILI will prospectively enroll 500 subjects. The primary endpoint is target vessel failure (TVF) at one year, defined as a composite of cardiac death, myocardial infarction (MI) according to the Academic Research Consortium-2 (ARC-2) definition (except for an MI clearly attributed to a non-target vessel) and revascularization of the target vessel. All endpoints are evaluated and confirmed by an independent adjudication committee. ConclusionThis national prospective academic registry will provide fruitful data on IVL in an unselected population of complex coronary lesions.