International Registry to Evaluate Safety and Effectiveness of Excimer Laser Coronary Atherectomy ELCA in Treating Stable and Acute Coronary Artery Disease During Percutaneous Coronary Intervention

What this Trial Is About

Researchers are evaluating the use of Excimer Laser Coronary Atherectomy ELCA during percutaneous coronary intervention PCI in patients with stable coronary artery disease or acute coronary syndromes. This observational registry study aims to assess the safety and effectiveness of ELCA during the initial PCI procedure and hospital stay, as well as at 30 days and one year after treatment. The study also examines procedural details to understand the learning curve and impact on catheter lab workflow. Participants will undergo ELCA treatment following standard hospital care instructions during PCI to treat significant coronary artery narrowing or blocked arteries. The study will include 500 patients across 20 sites in Europe, the United Kingdom, and India. Patients will be followed for one year, with assessments at screening, on the procedure day, at discharge, and during follow-ups at 1 month and 1 year. During the study, participants will have evaluations including intracoronary imaging and monitoring of procedural characteristics such as fluoroscopy time and contrast volume. Researchers will measure procedural success, hospital major adverse cardiovascular events, and longer-term outcomes like target lesion failure and stent optimization. Follow-up visits will allow safety monitoring and assessment of the devices performance over time, with a total study duration of about three years including recruitment and follow-up.

Coronary Laser Atherectomy Registry From an International Taskforce