Concurrent OPTIcal Coherence Tomography and frActional Flow REserve-guided Therapeutic Intervention in Patients With Coronary Artery Disease (OPTICARE-CAD)

What this Trial Is About

Researchers are evaluating the treatment strategies for patients with coronary artery disease undergoing stent implantation. This trial compares whether using combined guidance from optical coherence tomography (OCT) and fractional flow reserve (FFR) during the procedure improves outcomes compared to the standard approach guided only by conventional coronary angiography. The study aims to clarify if the combined method offers better clinical effectiveness and therapeutic impact than angiography alone. Participants are randomly assigned to one of two groups: one group will receive percutaneous coronary intervention (PCI) guided by conventional angiography, where procedural decisions are based on angiographic imaging. The other group will undergo PCI guided concurrently by both OCT and FFR, with procedural optimization determined by these combined assessments. Both strategies involve coronary stent implantation and evaluation of lesion and stent status using their respective imaging or physiological methods. During the study, participants will be monitored for one year to assess the rate of target vessel failure as the primary outcome. Secondary outcomes include the rates of all-cause mortality, myocardial infarction, target vessel revascularization, any revascularization, stent thrombosis at various stages, and bleeding events defined by BARC criteria. The study includes informed consent, clinical follow-up, and outcome assessments to evaluate the benefits and risks of the two PCI guidance methods over the year following intervention.

Concurrent OCT and FFR-guided PCI in CAD