IN-Stent RestenosIs Detection and Treatment by Optical Coherence Tomography Comparing OCT-Guided Versus Angiography-Only PCI for Coronary In-Stent Restenosis

What this Trial Is About

Researchers are investigating the treatment of coronary in-stent restenosis (ISR), a condition where the artery narrows again after stent placement, despite advances in drug-eluting stents. This trial compares two methods of guiding percutaneous coronary intervention (PCI) for ISR: one using intracoronary optical coherence tomography (OCT) along with angiography, and the other using angiography alone. The goal is to understand whether OCT guidance improves acute PCI performance for ISR patients. Participants with ISR showing 70% to 99% narrowing in a vessel between 2.25 and 5.75 mm will be randomly assigned to two groups. The first group will have PCI guided by OCT and angiography, with OCT runs before and after PCI, and additional OCT imaging allowed during the procedure. The second group will have PCI guided only by angiography, but OCT imaging will still be performed before and after PCI without the operator seeing the OCT results to maintain blinding. Operators in both groups may use various approved tools and techniques during PCI as needed. During the study, patients will undergo imaging and PCI procedures with detailed documentation of the treatment plans and any changes after OCT review. Researchers will measure changes in artery cross-sectional area after PCI as the primary outcome. Safety and procedural details will be closely monitored. The total participation includes the PCI procedure and follow-up imaging to assess treatment effectiveness.

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