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To treat patients with stable coronary artery disease, elective percutaneous coronary intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard drug-eluting stent (DES). Vascular responses at the site of stent placement will be evaluated by optical coherence tomography (OCT) at 1 or 3 months and at 12 months after stent placement, along with observation of changes over time in the target vessel. The relationships between OCT findings and the time course of platelet aggregation and between OCT findings and the occurrence of major cardio- cerebrovascular events will also be elucidated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 month OCT follow-up, CoCr-EES | Experimental | Elective PCI can be performed with the use of an EES. PCI in another vessel or follow-up angiography is expected to be performed 3 months after the index procedure. |
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| 1 month OCT follow-up, CoCr-EES | Experimental | Elective PCI can be performed with the use of an EES. PCI in another vessel or follow-up angiography is expected to be performed 1 months after the index procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoCr-EES | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of stent-strut coverage determined by OCT. | Rate of stent-strut coverage determined by OCT at 3 months after stent placement (To observe temporal course from the early stage, the rate of stent-strut coverage in the 1-month arm will also be evaluated in a complementary manner, separately from the 3-month arm.) To identify the factors defining the strut coverage at 1-month or 3-months, from OCT index, blood markers, platelet aggregation test immediately after stenting, the strut coverage of 1 to 3 months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Death, Cardiac death, MI, Stroke, Major bleeding | All-cause Death, Cardiac death, MI, Stroke, Major bleeding | 1-year |
| Any TLR | Any target lesion revascularization at 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet Aggregation Test | (1) at the time of PCI, (2) at the time of OCT at 1 or 3 months after PCI, (3) at 12-month follow-up, and (4) at the time of occurrence of a cardio-cerebrovascular event. | At the time of OCT follow-up (1 month or 3 month) and 12 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toshiro Shinke, MD, PhD | Kobe University Graduate School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kobe University Graduate School of Medicine | Kobe | 657-850 | Japan |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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This study will comprise of 1 month follow-up and 3-month follow up arm, which enroll patients in a parallel manner.
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All patients' information will be blinded to OCT image analyzers.
| 1-year |
| Clinically-driven TLR | Clinically relevant revascularization, such as ischemia driven intervention | 1 year |
| Any TVR | Any target vessel revascularization including both target lesion and remote lesion. | 1 year |
| CABG | Coronary artery bypass grafting | 1 year |
| Any revascularization | Any revascularization including percutaneous intervention and surgical bypass grafting | 1 year |
| Angiographic binary restenosis | Angiographic restenosis defined as percentage of diameter stenosis more than 50% at target lesion | 12 month |
| Patient-oriented composite | All-cause death, Any MI including non-target territory, Any repeat revascularization ,Stroke | 1 year |
| The percentage of stent strut coverage by OCT | Determination of factors associated with 12-month rate of stent-strut coverage on the basis of OCT findings, circulating biomarkers, and platelet aggregation test results immediately after stent placement | 12 month |
| OCT endpoint |
| 1-month or 3-month |
| Angiographic Quantitative analysis |
| 12 month |
| Angiographic Qualitative analysis |
| 12 month |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |