Acute coronary syndrome Acute coronary syndrome
Conditions
Interventions
OFDI group: If possible, OFDI imaging will be performed before stent implantation. Stenting will be performed with OFDI guidance according to local standard practice. At the end of the procedure, a fi
Sponsors
Otake Hiromasa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged between 20 and 85 years old 2) Patients (or their legally acceptable representatives) who provided written informed consent 3) Patients with ACS who will undergo drug-eluting stent implantation for a de novo lesion in a native coronary artery 4) The target lesion must have a visually estimated reference vessel diameter of 2.25 mm to 3.50 mm.
Exclusion criteria
Exclusion criteria: 1) Patients with cardiogenic shock 2) Patients with renal failure (eGFR =1.5mg/dL) 3) Patients on dialysis 4) Women who are pregnant or potential pregnancy 5) Patients who are currently enrolled or scheduled to be enrolled in other clinical trial which has possibility to influence the endpoints of OPINION-ACS trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimum lumen area by OFDI at 8 months after PCI | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) OFDI findings at just after the PCI (minimum stent area, minimum lumen area, thrombus, irregular protrusion, edge dissection, hematoma) 2) OFDI findings at 8 months after the PCI (mean neointima thickness, neointima area, mean lumen area, uncovered struts, malapposed struts) | — |
Contacts
Public ContactHiromasa Otake
Kobe University Hospital
Outcome results
None listed