Clinical Trial

Coronary Laser in Undilatable or Uncrossable Lesions

Study acronym: LUDICO
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
This will be an investigator-initiated, multicentre, single-arm, open-label, prospective observational study. Patients with indication for PCI and undilatable (non-compliant balloon dilatation \<80% at burst pressure) or uncrossable (not crossable with a "small-profile balloon" with adequate support, according to operator´s discretion) coronary lesions treated with ELCA will be included. Intravascular imaging will be highly recommendable and analysed in a central core-laboratory. Device success, angiographical success, procedural success, clinical success and related complications will be evaluated. Patients will be followed for 1 year after the procedure and clinical events will be recorded.
Trial Details
NCT Number NCT07206082
Lead Sponsor Hospital Universitario La Paz
Conditions Coronary Artery Disease, Calcified Coronary Artery Disease, In Stent Restenosis, Chronic Total Occlusion (CTO)
Enrollment 230 participants
Start Date 2020-06-05
Primary Completion 2025-03-10 (estimated)
Study Completion 2025-10-20 (estimated)
Updated on ClinicalTrials.gov 2025-10-03