Evaluation of Orbital Atherectomy Device Safety and Efficacy for Calcified Coronary Lesions in Patients with Coronary Artery Disease: The Lower Silesian Orbital Atherectomy Registry (LOAR)

What this Trial Is About

This research focuses on patients with moderately to severely calcified lesions in their coronary arteries who undergo percutaneous coronary intervention (PCI). The study aims to collect data on the safety and effectiveness of PCI when supported by the Orbital Atherectomy Device. Patients are selected based on clinical indication according to current European Society of Cardiology guidelines and the presence of significant calcification assessed by angiography or intravascular imaging techniques like IVUS or OCT. The study involves patients treated at two cardiac centers in Poland where the decision to use the Orbital Atherectomy Device during PCI is made by the operator based on lesion characteristics. Moderate calcification is defined as involving 30% to 50% of the lesion diameter, while severe calcification involves more than 50%. The procedure details, including additional lesion preparation, stent implantation, medication, and imaging use, are determined by the treating physician. All patients give informed consent after being advised about treatment options and risks. Participants will be monitored at discharge up to 10 days to assess clinical success and any treatment-emergent adverse events. Long-term follow-up includes evaluation of major adverse cardiac and cerebrovascular events for up to five years after hospitalization, with assessments every six months. The study collects comprehensive data on treatment outcomes and safety during and after the procedure, supporting ongoing patient care and research.

Lower Silesian Orbital Atherectomy Registry (LOAR)