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

Primary Purpose

Coronary Artery Disease

Status
Active
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Cilostazol eluting stent system (CES-1)
Sponsored by
JIMRO Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Drug eluting stents, Coronary artery disease, Coronary artery stenosis, Myocardial ischemia, Angioplasty

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tokai University Hospital
  • Kitasato University Hospital
  • Saiseikai Yokohamashi Tobu Hospital
  • Showa University Fujigaoka Hospital
  • Mitsui Memorial Hospital
  • Teikyo University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cilostazol eluting stent system (CES-1)

Arm Description

Outcomes

Primary Outcome Measures

In-segment late lumen loss as measured by quantitative coronary angiography (QCA)

Secondary Outcome Measures

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.
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.
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
In-stent and in-segment %diameter stenosis (%DS) as measured by QCA
In-stent and in-segment %Angiographic Binary Restenosis (%ABR)
Neointima volume as measured by OCT/OFDI
%Volume obstruction as measured by OCT/OFDI
%Incomplete stent apposition (%ISA) as measured by OCT/OFDI
%Covered strut as measured by OCT/OFDI

Full Information

First Posted
June 13, 2017
Last Updated
September 26, 2023
Sponsor
JIMRO Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03189641
Brief Title
Clinical Trial of Cilostazol Eluting Stent System (CES-1) in De Novo Coronary Artery Lesions
Official Title
An Exploratory Clinical Trial of Cilostazol Eluting Stent System (CES-1) in De Novo Coronary Artery Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 31, 2017 (Actual)
Primary Completion Date
March 27, 2020 (Actual)
Study Completion Date
August 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JIMRO Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Drug eluting stents, Coronary artery disease, Coronary artery stenosis, Myocardial ischemia, Angioplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cilostazol eluting stent system (CES-1)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Cilostazol eluting stent system (CES-1)
Intervention Description
Implantation of drug eluting stent
Primary Outcome Measure Information:
Title
In-segment late lumen loss as measured by quantitative coronary angiography (QCA)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Device Success rate
Description
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.
Time Frame
Immediate post-procedure
Title
Procedure success rate
Description
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.
Time Frame
At the time of hospital discharge, expected 1or 2 days after of procedure
Title
Target Lesion Failure (TLF)
Time Frame
9 Months
Title
Target Vessel Failure (TVF)
Time Frame
9 Months
Title
Stent thrombosis
Time Frame
9 Months
Title
Patient Oriented Composite End point (POCE)
Description
POCE: All cause death, all myocardial infarction, or all revascularization with ischemia
Time Frame
9 Months
Title
In-stent and in-segment %diameter stenosis (%DS) as measured by QCA
Time Frame
9 Months
Title
In-stent and in-segment %Angiographic Binary Restenosis (%ABR)
Time Frame
9 Months
Title
Neointima volume as measured by OCT/OFDI
Time Frame
9 Months
Title
%Volume obstruction as measured by OCT/OFDI
Time Frame
9 Months
Title
%Incomplete stent apposition (%ISA) as measured by OCT/OFDI
Time Frame
9 Months
Title
%Covered strut as measured by OCT/OFDI
Time Frame
9 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: <Clinical selection criteria> Patients who have provided written informed consent. Patients who have evidence of myocardial ischemia confirmed by subjective symptoms (chest pain etc.), ST change in the electrocardiogram or objective findings. Patients who are at least 20 years old. <Angiographic selection 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 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. 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 Patients who cannot be given emergency coronary artery bypass grafting (CABG). 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 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 artery 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
Facility Information:
Facility Name
Tokai University Hospital
City
Isehara
State/Province
Kanagawa
Country
Japan
Facility Name
Kitasato University Hospital
City
Sagamihara
State/Province
Kanagawa
Country
Japan
Facility Name
Saiseikai Yokohamashi Tobu Hospital
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Showa University Fujigaoka Hospital
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Mitsui Memorial Hospital
City
Chiyoda
State/Province
Tokyo
Country
Japan
Facility Name
Teikyo University Hospital
City
Itabashi
State/Province
Tokyo
Country
Japan

12. IPD Sharing Statement

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

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