IN-Stent RestenosIs Detection and Treatment by Optical Coherence Tomography for Coronary In-stent Restenosis

What this Trial Is About

Researchers are evaluating the use of intracoronary optical coherence tomography (OCT) guidance compared to angiography-only guidance during percutaneous coronary intervention (PCI) to treat coronary in-stent restenosis (ISR). ISR remains a challenge despite advances in drug-eluting stents, and this trial aims to understand whether OCT can improve acute PCI outcomes by providing more detailed imaging guidance. The study is a randomized, multicenter, non-blinded trial including patients with acute coronary syndrome or stable ischemic heart disease who have ISR requiring PCI. Participants will be randomly assigned to one of two groups: PCI guided by OCT plus angiography or PCI guided by angiography alone. In the OCT group, operators perform at least one OCT imaging run before and after PCI and may perform additional OCT runs during the procedure. In the angiography-only group, operators perform PCI guided by angiography, but OCT imaging is also done before and after PCI without the operator seeing the results to allow outcome comparison. Operators use standard PCI tools and techniques at their discretion in both groups. During the study, participants undergo diagnostic angiography followed by PCI with assigned imaging guidance. Researchers will assess the cross-sectional area of the treated coronary segment before and after PCI using imaging techniques. Additional data collected include the number of PCI maneuvers, intracoronary devices used, and quantitative flow ratio values. Participants will be followed for one year to monitor major adverse cardiovascular events. The total participation period includes the PCI procedure and follow-up evaluations up to one year post-procedure.

Intracoronary Optical Coherence Tomography Guidance Vs. Angiography Only Guidance for Treatment of Coronary In-stent Restenosis