Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons (RECORD-DCB)

What this Trial Is About

Researchers are systematically collecting and analyzing real-world data on patients undergoing percutaneous coronary intervention (PCI) using the Protégé paclitaxel-eluting drug-coated balloon (DCB). The study aims to evaluate procedural outcomes, long-term effectiveness, and safety of DCB therapy across various clinical indications, including stable coronary artery disease (CAD), acute coronary syndromes (ACS), and different lesion types such as in-stent restenosis, de novo lesions, small vessel disease, bifurcation lesions, calcified lesions, and bypass graft lesions. It also seeks to identify factors predicting success, complications, and optimal treatment approaches to improve DCB use. This observational registry includes patients treated with the Protégé paclitaxel-eluting DCB during PCI procedures. Eligible patients have de novo or in-stent restenosis lesions in native coronary arteries or bypass grafts with vessel diameters between 2.0 and 4.5 mm and are suitable for dual antiplatelet therapy. The study follows each patient for one year after enrollment to track outcomes such as target lesion failure (TLF). Participants will be monitored from enrollment through one year of follow-up to assess the primary outcome of target lesion failure. Data collection focuses on procedural details, long-term efficacy, and safety across diverse patient groups and lesion types. This registry provides insights into clinical effectiveness and guides treatment strategies involving DCB therapy in real-world practice.

Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons