Coronary Artery Disease
Conditions
Keywords
Drug eluting stents, Coronary artery disease, Coronary artery stenosis, Myocardial ischemia, Angioplasty
Brief summary
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.
Interventions
DEVICECilostazol eluting stent system (CES-1)
Implantation of drug eluting stent
Sponsors
JIMRO Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\<Clinical selection criteria\> 1. Patients who have provided written informed consent. 2. Patients who have evidence of myocardial ischemia confirmed by subjective symptoms (chest pain etc.), ST change in the electrocardiogram or objective findings. 3. Patients who are at least 20 years old. \<Angiographic selection criteria\> 1. Single de novo lesion in native coronary arteries 2. Target vessel diameter is 2.75 mm to 3.25 mm. 3. TIMI flow is 2 or more. 4. Angiographic percent diameter stenosis (by visual estimation) is 75% or more in AHA classification
Exclusion criteria
\<Clinical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-segment late lumen loss as measured by quantitative coronary angiography (QCA) | 9 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure success rate | At the time of hospital discharge, expected 1or 2 days after of procedure | 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. |
| Target Lesion Failure (TLF) | 9 Months | — |
| Target Vessel Failure (TVF) | 9 Months | — |
| Stent thrombosis | 9 Months | — |
| Patient Oriented Composite End point (POCE) | 9 Months | POCE: All cause death, all myocardial infarction, or all revascularization with ischemia |
| Device Success rate | Immediate post-procedure | 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. |
| 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 | — |
| In-stent and in-segment %diameter stenosis (%DS) as measured by QCA | 9 Months | — |
Countries
Japan
Outcome results
None listed