None listed
Conditions
Interventions
Drug : This is a prospective, open-label, multicenter, randomized, registry-based clinical study of all patients undergoing percutaneous coronary intervention for coronary artery disease.
Enrolled su
Sponsors
Korea University Anam Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. adult men and women 18 years of age or older Patients undergoing percutaneous coronary intervention using intravascular imaging for coronary artery disease. 3. 3. At least one major native coronary artery “target vessel” that meets all of the following criteria for intracoronary imaging immediately following a qualifying PCI procedure: A. Angiographic evidence of coronary artery stenosis greater than or equal to 30% by angiographic visual estimation B. Target vessel must be accessible to the imaging catheter and suitable for intracoronary imaging in its proximal (50 mm) segment (the “target segment”) C. Target vessel cannot be a bypass (aortic or saphenous vein or artery) graft or a bypassed graft vessel D. Target vessel must not have undergone a previous PCI within the Target Segment E. Target vessel must not be a procedure candidate at the time of eligible PCI or for 6 months thereafter (as determined by the investigator) 4. Patient is willing to participate voluntarily through written informed consent
Exclusion criteria
Exclusion criteria: 1. left main lesion: left main coronary artery stenosis greater than 50% by coronary angiographic visual estimation 2. history of coronary artery bypass graft surgery (CABG) Unstable clinical condition (hemodynamic or electrical instability) 4. Severe coronary artery calcification or tortuosity judged to interfere with IVUS, NIRS, assessment 5. Uncontrolled cardiac arrhythmia: recurrent and symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response, not controlled by medication within 3 months prior to screening. 6. 6. active liver disease or hepatic dysfunction Known allergy to contrast media, heparin, aspirin, ticagrelor, or prasugrel. 8. Known active infection or major hematologic, metabolic, or endocrine dysfunction, as determined by the investigator 8. Planned surgery within 12 months. 10. Currently enrolled in another investigational device or drug study 10. 11. estimated life expectancy of less than 2 years 12. female of childbearing potential (< 50 years of age and last menstrual period within the last 12 months), who has not had a tubal ligation, oophorectomy, or hysterectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy metric calculated by Intravascular Ultrasound(Change in coronary Percentage Atheroma Volume(PAV)) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in total Lipid Core Burden Index (LCBItotal) measured by near-infrared spectroscopic intravascular ultrasound;Change in Maximum Lipid Core Burden Index (maxLCBI4mm) within a 4-mm interval measured by Near Infrared Spectroscopy Intravascular Ultrasound;Change in total atherosclerotic plaque volume (NTAV) after correction as measured by near-infrared spectroscopy intravascular ultrasound;Changes in low-density cholesterol, high sensitivity C Reactive Protein, high sensitivity Troponin tropomyosin, N Terminal pro B type Natriuretic Peptide, lipids, and inflammatory markers and their association with plaque progression/regression indices;All deaths;Nonfatal myocardial infarction;Ischemic stroke;Ischemic coronary revascularization;New onset of diabetes;Incidence of statin-associated muscle symptoms (SAMS);Cataract incidence;Medication compliance | — |
Countries
Korea, Republic of
Contacts
Public ContactMinJoo Kim
Korea University Anam Hospital
Outcome results
None listed