Ischemic heart disease (stable angina, unstable angina, NSTEMI, STEMI) Myocardial Ischemia
Conditions
Interventions
Perform percutaneous coronary intervention (PCI) using standard techniques, and implant an everolimus-eluting stent to completely cover the vulnerable plaque.
Sponsors
Yamaji Kyohei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria will be included: 1. Aged 18 years or older at the time of obtaining informed consent. 2. Signed informed consent has been obtained from the subject. 3. Have at least one non-ischemic moderate stenosis that meets all of the following criteria: 1. Visual assessment on coronary angiography shows a vessel diameter of >=2.5 mm and a stenosis >=50%. 2. No functional ischemia has been diagnosed. 3. Vulnerable plaque is identified by OCT (optical coherence tomography).
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded: 1. Have a serious underlying disease with an expected prognosis of less than one year. 2. Have cardiogenic shock or decompensated heart failure requiring endotracheal intubation, vasopressors, or hemodynamic support devices. 3. Have a history of or are scheduled to undergo coronary artery bypass grafting (CABG). 4. Have a left main coronary artery lesion. 5. Have a history of bleeding tendency or a known coagulation disorder. 6. Have a known allergy to any of the drugs required in this protocol, including aspirin, P2Y12 inhibitors (prasugrel, clopidogrel, ticagrelor), heparin, or iodinated contrast agents (if not adequately managed by premedication).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of target vessel failure (TVF), defined as a composite endpoint of cardiovascular death, target vessel myocardial infarction, and clinically indicated target vessel revascularization during a 3-year follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| The 3-year incidence of the following events: Death Cardiovascular death Target vessel myocardial infarction Periprocedural myocardial infarction Non-periprocedural myocardial infarction Any myocardial infarction Target lesion revascularization Target vessel revascularization Non-target lesion revascularization Non-target vessel revascularization Any coronary artery revascularization Definite stent thrombosis Probable stent thrombosis For all myocardial infarctions, it will be assessed whether they are periprocedural myocardial infarctions. Similarly, for all revascularizations, it will be assessed whether they are clinically indicated. The relationship between the presence of vulnerable plaque, as determined by AI, and clinical events will be evaluated. | — |
Contacts
Public ContactKyohei Yamaji
Kyoto University Hospital
Outcome results
None listed