Clinical Trial of Cilostazol Eluting Stent System (CES-1) in De Novo Coronary Artery Lesions

Coronary Artery Disease Clinical Trial

Official title:

An Exploratory Clinical Trial of Cilostazol Eluting Stent System (CES-1) in De Novo Coronary Artery Lesions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03189641
• Other study ID #: JD-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 31, 2017
• Est. completion date: August 10, 2024

Study information

• Verified date: September 2023
• Source: JIMRO Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: August 10, 2024
• Est. primary completion date: March 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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 exclusion criteria>

1. 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.

• 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).

• Pathological Q waves on electrocardiogram

• Myocardial necrotic focus or wall motion abnormality newly confirmed in diagnostic imaging

2. Patients who cannot be given emergency coronary artery bypass grafting (CABG).

3. Patients who cannot be administered antiplatelet drugs. The following cases are conceivable.

• Significant intracranial hemorrhage, gastrointestinal bleeding, urinary tract hemorrhage etc. within the last 6 months

• Surgical operation is planned that requires discontinuation of DAPT after the procedure

• Anticoagulation therapy is underway and the risk of bleeding is high

4. Bleeding tendency due to hemorrhagic diathesis or blood coagulation disorder.

5. Left ventricular ejection fraction (LVEF) is less than 30% within 30 days before the trial registration.

6. Renal dysfunction (Creatinine value exceeds 2.0 mg/dl or in case artificial dialysis).

7. Allergy to cobalt chrome alloy or contrast agent.

8. 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.

9. Patients who are pregnant or breast feeding.

10. Patients who are taking Cilostazol.

11. In cases where the Investigator determines that the patient's participation in the trial is inappropriate.

<Angiographic exclusion criteria>

1. Lesion in left main coronary trunk

2. Lesion within 5 mm from the ostium right coronary artery

3. Lesion within 5 mm from the ostium left anterior descending/the ostium left circumflex branch

4. Bifurcation lesion

5. Within 1 year after implementing PCI on the target vessel or its branch

6. There are other lesions that require PCI at the time of the procedure

7. Type C of ACC / AHA classification

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Cilostazol eluting stent system (CES-1)
Implantation of drug eluting stent

Locations

Country	Name	City	State
Japan	Mitsui Memorial Hospital	Chiyoda	Tokyo
Japan	Tokai University Hospital	Isehara	Kanagawa
Japan	Teikyo University Hospital	Itabashi	Tokyo
Japan	Kitasato University Hospital	Sagamihara	Kanagawa
Japan	Saiseikai Yokohamashi Tobu Hospital	Yokohama	Kanagawa
Japan	Showa University Fujigaoka Hospital	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
JIMRO Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-segment late lumen loss as measured by quantitative coronary angiography (QCA)		9 months
Secondary	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
Secondary	Procedure success rate	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
Secondary	Target Lesion Failure (TLF)		9 Months
Secondary	Target Vessel Failure (TVF)		9 Months
Secondary	Stent thrombosis		9 Months
Secondary	Patient Oriented Composite End point (POCE)	POCE: All cause death, all myocardial infarction, or all revascularization with ischemia	9 Months
Secondary	In-stent and in-segment %diameter stenosis (%DS) as measured by QCA		9 Months
Secondary	In-stent and in-segment %Angiographic Binary Restenosis (%ABR)		9 Months
Secondary	Neointima volume as measured by OCT/OFDI		9 Months
Secondary	%Volume obstruction as measured by OCT/OFDI		9 Months
Secondary	%Incomplete stent apposition (%ISA) as measured by OCT/OFDI		9 Months
Secondary	%Covered strut as measured by OCT/OFDI		9 Months