Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention

A Prospective, Open Label, Multi-center, Dual Arm, Randomized, Pragmatic Trial : Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention

The primary aim of this study is to compare the clinical efficacy and safety of OCT-guided(optical coherence tomography (OCT)-guided) and IVUS-guided(Intravascular ultrasound (IVUS)-guided) strategies in patients undergoing Percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) or drug-coated balloons (only for in-stent restenosis) for significant obstructive Coronary artery disease (CAD).

The investigators hypothesize that OCT-guided PCI is non-inferior to IVUS-guided PCI with respect to primary end point of target-vessel failure (cardiac death, target-vessel myocardial infarction [MI], or ischemia-driven target-vessel revascularization [TVR]) at 1 year after randomization.

Inclusion Criteria:

• Men or women at least 19 years of age
• Subjects with obstructive CAD undergoing PCI with contemporary DES or drug-coated balloons (only for in-stent restenosis) under intracoronary imaging guidance.
• The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

• ST-elevation myocardial infarction
• Severe renal dysfunction (eGFR <30 ml/min/1.73 m2 or serum creatinine level >1.5 mg/dl), unless patient is on renal replacement therapy.
• Cardiogenic shock or decompensated heart failure with severe LV dysfunction (LVEF) < 30%
• Life expectancy < 1 year for any non-cardiac or cardiac causes
• Any lesion characteristics resulting in the expected inability to deliver the IVUS or OCT catheter to the lesion pre- and post-PCI (eg, moderate or severe vessel calcification or tortuosity)
• Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study
• Unwillingness or inability to comply with the procedures described in this protocol