Ischemic heart disease
Conditions
Interventions
None listed
Sponsors
Kokura Memorial Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who is 20 years of age or older at informed consent 2. Patients who submit signed consent by themselves or their legally acceptable representative 3. Elective or ad hoc PCI in patients with stable angina, acute coronary syndrome, or silent myocardial ischemia for target lesions in the native coronary artery. Target lesions fulfill at least one of the following criteria: 1) visually estimated %diameter stenosis >=90%, 2) fractional flow reserve <0.80, instantaneous wave-free ratio <0.89 or 3) presence of myocardial ischemia assessed by non-invasive test such as scintigraphy, stress echocardiography, and stress electrocardiography. 4. Patients who had at least one non-target coronary artery in which 1) no previously treated lesions and 2) non-severe stenosis (30% < visually estimated %DS < 90%) in the non-target vessel or >5mm apart from the culprit lesions. Except for contraindication, physicians are encouraged to confirm the stenosis is not significant by fractional flow reserve test (i.e. FFR>=0.80), instantanoues wave-free ratio (i.e. iFR>=0.89) or non-invasive test.
Exclusion criteria
Exclusion criteria: 1. Subject with left main lesion. 2. Subject with a history of coronary artery bypass grafting. 3. Known renal insufficiency (estimated serum creatinine clearance <30ml/min or maintenance hemodialysis). 4. Severe angulation (>90 degrees) or excessive tortuosity (>two 45 degrees angles) not suitable for OCT assessments. 5. Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy 6. Life expectancy less than 1 year. 7. Known allergy against protocol-required medications including aspirin, prasugrel, clopidogrel, heparin, iodinated contrast (the latter in case it cannot be adequately premedicated). 8. Cardiogenic shock or decompensate heart failure requiring intubation, vasopressors, and hemodynamic support (IABP and/or PCPS). 9. History of bleeding diathesis or known coagulopathy. 10. Planned surgery within the next 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in lumen area in the non-significant stenosis (%DS 30%-90%) assessed by OCT from baseline to 12-month follow-up. Matching will be done using anatomical landmarks such as side branches and ostium of the coronary arteries. Following OCT parameters will be assessed in paired frames between baseline and follow-up. -Luminal area -Fibrous cap thickness -Lipid arc, lipid length -Calcification arc, calcification length) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary clinical endpoints Any death, cardiac death, non-fatal myocardial infarction, and any ischemia-driven coronary artery revascularization. Secondary safety endpoints Amount of contrast used, cumulative radiation dose, intervention time, and any OCT procedure related adverse events. Secondary CT endpoints Changes in lumen volume in the non-culprit vessels assessed by computed tomography from baseline to 36-month follow-up. | — |
Countries
Japan
Contacts
Public ContactKyohei Yamaji
Kokura Memorial Hospital Division of Cardiology
Outcome results
None listed