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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Cilostazol eluting stent system (CES-1)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Kanagawa
    • Isehara, Kanagawa, Japan
      • Tokai University Hospital
    • Sagamihara, Kanagawa, Japan
      • Kitasato University Hospital
    • Yokohama, Kanagawa, Japan
      • Saiseikai Yokohamashi Tobu Hospital
    • Yokohama, Kanagawa, Japan
      • Showa University Fujigaoka Hospital
  • Tokyo
    • Chiyoda, Tokyo, Japan
      • Mitsui Memorial Hospital
    • Itabashi, Tokyo, Japan
      • Teikyo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cilostazol eluting stent system (CES-1)	Device: Cilostazol eluting stent system (CES-1); Implantation of drug eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-segment late lumen loss as measured by quantitative coronary angiography (QCA)	9 months

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: JIMRO Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2017
• Primary Completion (Actual): March 27, 2020
• Study Completion (Estimated): August 10, 2024

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Coronary artery disease; Angioplasty; Drug eluting stents; Myocardial ischemia; Coronary artery stenosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Neuroprotective Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Cilostazol
• Other Study ID Numbers: JD-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No