Study on Safety and Effectiveness of Rotational Atherectomy and Ultrasound Imaging for Treating Severe Calcium Build-up in Coronary Arteries in Asia

What this Trial Is About

Researchers are observing patients with severe calcified coronary artery lesions undergoing rotational atherectomy RA in multiple centers across Asia. The study aims to evaluate the safety and effectiveness of RA, with or without other calcium removal therapies, as an additional procedure during percutaneous coronary intervention PCI. This observational study collects detailed patient and procedural data to better understand outcomes and procedural success in this population. Participants will undergo RA procedures as part of their clinical care, with data gathered before, during, and after PCI. Informed consent is obtained either before PCI with planned RA or within 48 hours after the procedure. Data collection includes patient history, demographics, lab results, symptoms, procedural details, and any serious adverse events. Follow-up includes a telephone check at 12 months post-procedure. For patients who died or did not consent, data is collected retrospectively from hospital records to provide a comprehensive overview. Participants will provide information via electronic or paper forms, and researchers will collect clinical, laboratory, imaging, and angiographic data. The primary outcome measured is procedural success based on procedure duration. Secondary outcomes include death within one year, heart attacks, and complications within 48 hours of the procedure. Data is anonymized and securely uploaded to a web-based platform. The study ensures ongoing monitoring and data collection for better understanding of RA outcomes in real-world practice.

ROVUS Asia Registry (Evaluate Safety and Effectiveness of Rotational Atherectomy and Intravascular Ultrasound for Heavily Calcified Coronary Lesion)