Coronary Artery Disease
Conditions
Interventions
OFDI Guided PCI in 400 patients
IVUS Guided PCI in 400 patients
Sponsors
Translational Research Informatics Center, Foundation for Biomedical Research and Innovation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients eligible for PCI using drug-eluting stent for native coronary artery 2) Patients aged between 20 and 85 years old 3) Patients who has provided written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with AMI within 3 months 2) Patients with cardiogenic shock 3) Patients with chronic heart failure 4) Patients with renal failure (eGFR <= 30 ml/min/1.73 m2 or Serum creatinine level >=1.5mg/dL) 5) Patients who is currently enrolled other clinical trial which has possibility to influence the primary endpoint of OPINION trial. 6) Patients planned use of bare metal stent 7) 3 vessel diseases 8) Patient who is scheduled to undergo surgical operation within 1 year. 9) Patient on dialysis 10) Target lesion such as: - Left main coronary artery - Aorto-Ostial lesion location within 3mm of the aorta junction - Chronic total occlusion - Small vessel (<2.5mm) - Coronary artery bypass graft - In-stent restenosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of cardiac death, target vessel-related myocardial infarction (MI) and clinically-driven target vessel revascularization(TVR) at 12 months after PCI(Target Vessel Failure:TVF) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac death, MI, Clinically-driven Target lesion revascularization(TLR), MACE (composite of cardiac death, MI, TLR), TVR, Stroke, Stent thrombosis, Binary restenosis, Renal dysfunction at 12 months after PCI | — |
Countries
Japan
Contacts
Public ContactTakashi Kubo
Wakayama Medical University Department of Cardiovascular Medicine
Outcome results
None listed