ILUMIEN III: OPTIMIZE PCI OPtical Coherence Tomography (OCT) Compared to Intravascular Ultrasound (IVUS) and Angiography to Guide Coronary Stent Implantation: a Multicenter RandomIZEd Trial in PCI

INTERVENTION: Intervention type:DEVICE. Intervention1:Randarmization, Dose form:DEVICE, Route of administration:INTRACORONARY, intended dose regimen:NA. Control intervention1:Intravascular Ultrasound (IVUS), Dose form:DEVICE, Route of administration:INTRACORONARY, Intended dose regimen:NA., Control intervention2:Angiography, Dose form:DEVICE, Route of administration:INTRACORONARY. CONDITION: Subjects undergoing PCI for: ‐Angina (stable or unstable) ‐Silent ischemia (at least one of the following must be present: a visually estimated target lesion diameter stenosis of ?70%, a positive non‐invasive stress test, or FFR ?0.80) ‐NSTEMI ‐Recent STEMI (>24 hours from initial presentation and stable) PRIMARY OUTCOME: Primary Efficacy Endpoint (powered). Post‐PCI MSA assessed by OCT in each randomized arm, measured at the independent OCT core laboratory blinded to imaging modality assignment. Testing will be done in a hierarchal manner as follows:; 1. Non‐inferiority of OCT guided stenting to IVUS guided stenting; 2. Superiority of OCT guided stenting to Angiography guided stenting; 3. Superiority of OCT guided stenting to IVUS guided stenting; Primary Safety Endpoint (non‐powered). Procedural MACE defined as procedural complications (angiographic dissection, perforation, thrombus, and acute closure) requiring active interventions (prolonged balloon inflations, additional stent implantations, or pericardiocentesis).. Timepoint:Procedure. INCLUSION CRITERIA: General INCLUSION CRITERIA: 1) Age greater than or equal to 18 years 2) Patient with an indication for PCI including: ‐ Angina (stable or unstable), ‐ Silent ischemia (a visually estimated target lesion diameter stenosis of greater than or equal to 70%, a positive non‐invasive stress test, or FFR less than or equal to 0.80 must be present), ‐ NSTEMI, or ‐ Recent STEMI (>24 hours from initial presentation and stable). 3) Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non‐investigational metallic drug‐eluting stent (DES) 4) Signed written informed consent Angiographic INCLUSION CRITERIA: 1) The target lesion must be located in a native coronary artery with visually estimated reference vessel diameter of greater than or equal to 2.25 mm to less than or equal to 3.50 mm. 2) Lesion length <40mm Note: Overlapping stents are allowed