Ischemic Heart Disease,percutaneous coronary intervention
Conditions
Interventions
PCI with standard coronary angiography guide
PCI with Optical coherence tomography (OCT) guidance
Sponsors
Wakayama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) patients with stable angina pectoris or unstable angina pectoris or non-ST elevation type acute myocardial infarction patients (judged based on the guidelines) having a PCI adaptation new lesion in the coronary artery using a drug eluting stent 2) Patients who aged 20 years or older at the time of acquisition 3) Patients who gained written consent by the patient
Exclusion criteria
Exclusion criteria: 1) Patients with ST elevation myocardial infarction(STEMI) 2) Hemodynamic supplements or vasopressors with cardiogenic shock (defined as persistent hypotension with systolic blood pressure <90mm/Hg persisting for more than 30 minutes) or pressure rising/intra-aortic balloon pumping at the time of the procedure Required patient 3) Heart failure patients 4) Patients with three branches disease 5) Patients planned to use bare metal stent (BMS) 6) Patients with renal dysfunction (eGFR 30ml/min/1.73m2 or less or serum creatinine 1.5mg/dl or more) 7) Patients during dialysis treatment 8) Patients who are known to have allergies to aspirin, clopidogrel, prasugrel, heparin, iodine contrast medium, 9) Patients with hemorrhagic complications such as intracranial hemorrhage and gastrointestinal bleeding 10) Patients planning surgical treatment with in 12month after PCI 11) Patients with one or more co-morbidities that shorten life expectancy to less than 12 months or that may interfere with the study process according to this study protocol 12) Patients participating in clinical trials of other medical devices and drugs and judged by the attending physician as affecting the main endpoint of this study 13) Patients scheduled to use IVUS for the PCI to be tested 14) Patients whose treatment subject lesion morphology falls under any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimum Stent Area (MSA) after PCI implementation by OCT evaluation | — |
Countries
Japan
Contacts
Public ContactKazuhiro Minagawa
CV quest Co., Ltd. Clinical Research Support Division
Outcome results
None listed