Design of the LUDICO study: effectiveness and safety of coronary laser in undilatable or uncrossable lesions

Introduction and objectives: Excimer laser coronary atherectomy (ELCA) is increasingly used in complex percutaneous coronary interventions (PCI), particularly in cases of "balloon failure," which includes both uncrossable and undilatable coronary artery lesions. Although these 2 scenarios represent distinct technical and clinical challenges, they are usually evaluated using the same safety and efficacy endpoints. As a result, there is a lack of specific evidence on the safety and efficacy profile of ELCA in each of these situations. Furthermore, the role of intracoronary imaging in optimizing ELCA use remains insufficiently defined. Methods: This will be an investigator-initiated, multicenter, single-arm, open-label, prospective observational study. Patients with an indication for PCI and undilatable (non-compliant balloon dilatation < 80% at burst pressure) or uncrossable (uncrossable with a "small-profile balloon" with adequate support, left to the operator's discretion) coronary artery lesions treated with ELCA will be included. Intravascular imaging will be highly advised and analyzed in a core laboratory. Device success, angiographical success, procedural success, clinical success and related complications will be evaluated. Patients will be postoperatively followed for 1 year and clinical events will be recorded. Conclusions: The LUDICO study will be a multicentre, prospective study of ELCA therapy in uncrossable or undilatable coronary lesions. The study aims to evaluate the safety and efficacy profile of ELCA in these lesions as well as the clinical results at the 1 year follow-up in this setting. (ClinicalTrials.gov: NCT07206082).