None listed
Conditions
Interventions
Procedure/Surgery : Patients undergoing coronary angiography for suspected or known CAD will be screened for eligibility. After providing a detailed explanation of the study, written informed consent
Sponsors
Seoul National University Hospital
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Patients aged 19 years or older ? Patients with moderate to severe coronary artery stenosis identified on coronary angiography: A. Diameter stenosis of 50%–90% by visual estimation B. De novo lesions (newly developed lesions) C. Reference vessel diameter = 2.5 mm by visual estimation ? Patients with either clinically high-risk features for recurrent ischemic events or complex high-risk lesions identified on angiography: A. Clinically high-risk features i. Medically treated diabetes mellitus ii. Chronic kidney disease (= Stage 3B, eGFR < 45 mL/min/1.73 m²) iii. Acute coronary syndrome (ACS) iv. Previous myocardial infarction (MI) B. Complex high-risk lesions i. True bifurcation lesions ii. Calcified lesions (moderate to severe calcification on angiography) iii. Diffuse long lesions (= 30 mm in length) iv. Multivessel disease v. Multiple lesions (= 3 lesions) ? Patients who can verbally demonstrate an understanding of the risks, benefits, and alternative treatments of invasive physiologic or imaging assessment and PCI ? Patients who agree to the study protocol and clinical follow-up plan, voluntarily decide to participate, and provide written informed consent to participate in this clinical trial
Exclusion criteria
Exclusion criteria: ? Hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, prasugrel, ticagrelor, adenosine, or nicorandil ? Hemodynamic instability requiring mechanical circulatory support (ECMO or IABP) ? Moderate or severe stenosis of the left main coronary artery (diameter stenosis > 50%) ? History of coronary artery bypass grafting (CABG) ? Severe asthma or severe chronic obstructive pulmonary disease (COPD) ? Active bleeding ? Major gastrointestinal or genitourinary bleeding within the previous 3 months ? Bleeding diathesis or known coagulopathy, including a history of heparin-induced thrombocytopenia (HIT) ? Life expectancy < 2 years due to non-cardiovascular comorbidities ? Inability to provide signed informed consent ? Any condition deemed by the investigator to make the patient unsuitable for this clinical trial or likely to increase study-related risks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target vessel failure : a composite of cardiovascular death, target vessel myocardial infarction and ischemia-driven target vessel revascularization | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-oriented composite outcome: a composite of all cause of death, any myocardial infarction and any repeat revascularization;Target lesion failure: a composite of cardiovascular death, target vessel myocardial infarction and ischemia-driven target lesion revascularization;All cause death;Cardiovascular death;Any myocardial infarction;Peri-procedural myocardial infarction;Target vessel myocardial infarction;Definite or probable stent thrombosis;Ischemic or hemorrhagic stroke;Any revascularization;Ischemia-driven target vessel revascularization;Ischemia-driven target lesion revascularization;Number of stents used per patient or lesion;Bleeding Academic Research Consortium [BARC] type 2,3, or 5 | — |
Countries
Korea, Republic of
Contacts
Public ContactDoyeon Hwang
Seoul National University Hospital
Outcome results
None listed