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The purpose of the this trial is to evaluate the clinical safety and efficacy of Cilostazol eluting stent system (CES-1) for the treatment of single de novo lesions in native coronary arteries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cilostazol eluting stent system (CES-1) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilostazol eluting stent system (CES-1) | Device | Implantation of drug eluting stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-segment late lumen loss as measured by quantitative coronary angiography (QCA) | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success rate | Device success is defined as successfully placement of the investigational stent at the target lesion, and attainment of less than 50% residual stenosis at the end of stenting. | Immediate post-procedure |
| Procedure success rate |
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Inclusion Criteria:
<Clinical selection criteria>
<Angiographic selection criteria>
Exclusion Criteria:
<Clinical exclusion criteria>
Acute myocardial infarction Patients whose CK-MB or troponin exceeds the facility reference upper limit and have at least one of the following is confirmed are excluded as acute myocardial infarction.
Patients who cannot be given emergency coronary artery bypass grafting (CABG).
Patients who cannot be administered antiplatelet drugs. The following cases are conceivable.
Bleeding tendency due to hemorrhagic diathesis or blood coagulation disorder.
Left ventricular ejection fraction (LVEF) is less than 30% within 30 days before the trial registration.
Renal dysfunction (Creatinine value exceeds 2.0 mg/dl or in case artificial dialysis).
Allergy to cobalt chrome alloy or contrast agent.
Patients who are participating in or will planning to participate in other clinical studies that may have clinical implications for the evaluation of this trial.
Patients who are pregnant or breast feeding.
Patients who are taking Cilostazol.
In cases where the Investigator determines that the patient's participation in the trial is inappropriate.
<Angiographic exclusion criteria>
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokai University Hospital | Isehara | Kanagawa | Japan | |||
| Kitasato University Hospital |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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Procedure success is defined as attainment of less than 50% residual stenosis at the end of stenting and no major adverse cardiac events (death (excluding cases obviously caused by other than coronary ischemia), myocardial infarction, target lesion revascularization (TLR)) during hospitalization.
| At the time of hospital discharge, expected 1or 2 days after of procedure |
| Target Lesion Failure (TLF) | 9 Months |
| Target Vessel Failure (TVF) | 9 Months |
| Stent thrombosis | 9 Months |
| Patient Oriented Composite End point (POCE) | POCE: All cause death, all myocardial infarction, or all revascularization with ischemia | 9 Months |
| In-stent and in-segment %diameter stenosis (%DS) as measured by QCA | 9 Months |
| In-stent and in-segment %Angiographic Binary Restenosis (%ABR) | 9 Months |
| Neointima volume as measured by OCT/OFDI | 9 Months |
| %Volume obstruction as measured by OCT/OFDI | 9 Months |
| %Incomplete stent apposition (%ISA) as measured by OCT/OFDI | 9 Months |
| %Covered strut as measured by OCT/OFDI | 9 Months |
| Sagamihara |
| Kanagawa |
| Japan |
| Saiseikai Yokohamashi Tobu Hospital | Yokohama | Kanagawa | Japan |
| Showa University Fujigaoka Hospital | Yokohama | Kanagawa | Japan |
| Mitsui Memorial Hospital | Chiyoda City | Tokyo | Japan |
| Teikyo University Hospital | tabashi City | Tokyo | Japan |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |