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

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ClinicalTrials.gov Identifier: NCT03189641
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
JIMRO Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Cilostazol eluting stent system (CES-1) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Clinical Trial of Cilostazol Eluting Stent System (CES-1) in De Novo Coronary Artery Lesions
Actual Study Start Date : May 31, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Cilostazol

Arm Intervention/treatment
Experimental: Cilostazol eluting stent system (CES-1) Device: Cilostazol eluting stent system (CES-1)
Implantation of drug eluting stent




Primary Outcome Measures :
  1. In-segment late lumen loss as measured by quantitative coronary angiography (QCA) [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. 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.

  2. Procedure success rate [ Time Frame: 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.

  3. Target Lesion Failure (TLF) [ Time Frame: 9 Months ]
  4. Target Vessel Failure (TVF) [ Time Frame: 9 Months ]
  5. Stent thrombosis [ Time Frame: 9 Months ]
  6. Patient Oriented Composite End point (POCE) [ Time Frame: 9 Months ]
    POCE: All cause death, all myocardial infarction, or all revascularization with ischemia

  7. In-stent and in-segment %diameter stenosis (%DS) as measured by QCA [ Time Frame: 9 Months ]
  8. In-stent and in-segment %Angiographic Binary Restenosis (%ABR) [ Time Frame: 9 Months ]
  9. Neointima volume as measured by OCT/OFDI [ Time Frame: 9 Months ]
  10. %Volume obstruction as measured by OCT/OFDI [ Time Frame: 9 Months ]
  11. %Incomplete stent apposition (%ISA) as measured by OCT/OFDI [ Time Frame: 9 Months ]
  12. %Covered strut as measured by OCT/OFDI [ Time Frame: 9 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03189641


Contacts
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Contact: Jun Satomi 81334699351 jimro-clinical-des@otsuka.jp

Locations
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Japan
Tokai University Hospital Recruiting
Isehara, Kanagawa, Japan
Kitasato University Hospital Recruiting
Sagamihara, Kanagawa, Japan
Saiseikai Yokohamashi Tobu Hospital Recruiting
Yokohama, Kanagawa, Japan
Showa University Fujigaoka Hospital Recruiting
Yokohama, Kanagawa, Japan
Mitsui Memorial Hospital Recruiting
Chiyoda, Tokyo, Japan
Teikyo University Hospital Recruiting
Itabashi, Tokyo, Japan
Sponsors and Collaborators
JIMRO Co., Ltd.

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Responsible Party: JIMRO Co., Ltd.
ClinicalTrials.gov Identifier: NCT03189641     History of Changes
Other Study ID Numbers: JD-001
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019

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

Keywords provided by JIMRO Co., Ltd.:
Drug eluting stents
Coronary artery disease
Coronary artery stenosis
Myocardial ischemia
Angioplasty

Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Artery Disease
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cilostazol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors