Comparing Intravascular Ultrasound-Guided and Experienced Angiography-Guided Stenting for Left Main Coronary Artery Bifurcation Lesions A Prospective Randomized Clinical Trial

What this Trial Is About

Researchers are evaluating two strategies for optimizing stent implantation during bifurcation stenting of the left main coronary artery LM in patients with coronary artery disease. This prospective, randomized, controlled trial compares an intravascular ultrasound IVUS-guided approach versus an IVUS-trained eye approach based on angiographic assessment and operator experience. The study aims to determine whether an angiography-based method performed by experienced physicians is non-inferior to the IVUS-guided technique regarding stent placement quality and planimetric characteristics immediately after the procedure. All patients receive the same type of coronary stent Calypso, R-Vascular, Russia to reduce variability. The IVUS-guided group undergoes baseline IVUS assessment to select and optimize stent placement with mandatory steps like kissing balloon dilation and proximal optimization. The angiography-guided group relies on visual angiographic evaluation for stent and balloon selection, with IVUS used only after the procedure to assess stent results. Both groups follow the same optimization steps and procedural techniques. Participants are monitored immediately after the procedure with IVUS imaging to measure stent expansion and quality. Follow-up assessments occur up to one year post-procedure to evaluate device-oriented composite endpoints. The study includes detailed procedural steps, imaging, and clinical outcome tracking to compare the two approaches. Total participation lasts through the intervention and one year of follow-up to assess safety and effectiveness outcomes.

"Expert IVUS-Eye" vs. IVUS-guided Left Main Bifurcation PCI