An Exploratory Clinical Trial of Cilostazol Eluting Stent System (CES-1) in De Novo Coronary Artery Lesions
An Exploratory Clinical Trial of CES-1
JIMRO Co., Ltd.
jimro-clinical-des@otsuka.jp
JIMRO Co., Ltd.
jimro-clinical-des@otsuka.jp
completed
May. 31, 2017
30
Interventional
Multicenter, Non-masking, Single group
treatment purpose
2
Clinical inclusion criteria
- Patients who have evidence of myocardial ischemia confirmed by subjective symptoms (chest pain etc.), ST change in the electrocardiogram or objective findings.
Angiographic inclusion criteria
- Single de novo lesion in native coronary arteries.
- Target vessel diameter is 2.75 mm to 3.25 mm.
- TIMI flow is 2 or more.
- Angiographic percent diameter stenosis (by visual estimation) is 75% or more in AHA classification.
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.
i. Ischemic symptoms and Electrocardiographic findings showing continuous ischemia (eg, ST segment elevation or depression above 1 mm in contiguous leads, or the appearance of a new left bundle branch block).
ii. Pathological Q waves on electrocardiogram.
iii. Myocardial necrotic focus or wall motion abnormality newly confirmed in diagnostic imaging.
- Patients who cannot be given emergency coronary artery bypass grafting (CABG).
- Patients who cannot be administered antiplatelet drugs. The following cases are conceivable.
i. Significant intracranial hemorrhage, gastrointestinal bleeding, urinary tract hemorrhage etc. within the last 6 months.
ii. Surgical operation is planned that requires discontinuation of DAPT after the procedure.
iii. Anticoagulation therapy is underway and the risk of bleeding is high.
- 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
- Lesion in left main coronary trunk.
- Lesion within 5 mm from the ostium right coronary art.
- Lesion within 5 mm from the ostium left anterior descending/the ostium left circumflex branch.
- Bifurcation lesion.
- Within 1 year after implementing PCI on the target vessel or its branch.
- There are other lesions that require PCI at the time of the procedure.
- Type C of ACC/AHA classification.
20age old over
No limit
Both
Coronary Artery Disease
investigational material(s)
Generic name etc : Cilostazol eluting stent system (CES-1)
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : A Cilostazol eluting stent is implanted in the target lesion.
control material(s)
Generic name etc : -
INN of investigational material :
Therapeutic category code :
Dosage and Administration for Investigational material : -
efficacy
In-segment late lumen loss as measured by quantitative coronary angiography (QCA)
[Time Frame: 9 months]
safety
efficacy
Acute success
- Device Success rate [Time Frame: 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.
- Procedure success rate [Time Frame: At the time of hospital discharge]
* 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.
Clinical outcome measure [Time Frame: 9 Months]
- Target Lesion Failure (TLF)
- Target Vessel Failure (TVF)
- Stent thrombosis
- Patient Oriented Composite End point (POCE)
POCE: All cause death, all myocardial infarction, or all revascularization with ischemia
