Endovascular Treatment of Primary Common Femoral Artery Atherosclerotic Disease with Intravascular Lithotripsy (FESTIVAL): Early and Midterm Outcomes of a Prospective, Multicentre, Observational Registry

Objective: The aim of this study was to evaluate early and midterm outcomes of endovascular treatment of primary common femoral artery (CFA) atherosclerotic disease with intravascular lithotripsy (IVL) in the framework of a prospective, multicentre registry (FESTIVAL). Methods: This was an analysis of early and midterm clinical and morphological outcomes in a prospective multicentre study based on patients undergoing IVL without stenting in CFA disease. A prospective dataset of consecutive IVLs without stenting in the treatment of de novo CFA disease in 21 centres between January 2024 and February 2025 was investigated. The Azéma classification was used to classify CFA lesions. A shockwave IVL catheter was used in all cases. Follow up included clinical examination and duplex scan at discharge, 1 and 6 months, 1 year, and yearly thereafter. Primary outcome measures were primary patency, primary assisted patency, secondary patency, freedom from clinically driven target lesion re-stenosis (cdTLR), and freedom from any re-intervention(s). Results: During the study period, 117 patients were enrolled. Thirty day technical success was 97.4%. The median duration of follow up was 19 months (interquartile range 12, 27). Estimated 1 and 2 year rates were, respectively: primary patency, 96.2% and 93.9%; primary assisted patency, 96.2% and 93.9%; secondary patency, 100% and 100%; freedom from cdTLR, 95.2% and 92.6%; and freedom from any re-intervention(s), 96.2% and 91.9%. In multivariate analysis, Azéma type III lesion negatively affected primary patency (p = .042; odds ratio [OR] 4.131) and freedom from cdTLR (p = .048; OR 3.914). Conclusion: IVL without stenting in the treatment of de novo CFA steno-obstructive disease is a safe and effective procedure when the lesion does not extend to the femoral bifurcation. This procedure yields acceptable early and midterm overall patency with low rates of re-intervention.