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

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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

NCT03189641•JIMRO Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - No limit years

Sex

ALL

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

•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.
+14 more criteria

Locations (6)

Tokai University Hospital

Isehara, Kanagawa, Japan

Kitasato University Hospital

Sagamihara, Kanagawa, Japan

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa, Japan

Showa University Fujigaoka Hospital

Yokohama, Kanagawa, Japan

Mitsui Memorial Hospital

Chiyoda City, Tokyo, Japan

Teikyo University Hospital

tabashi City, Tokyo, Japan

Key Dates

Start Date

May 31, 2017

Primary Completion Date

March 27, 2020

Completion Date

July 26, 2024

Last Updated

March 14, 2025

Enrollment

ACTUAL participants

Conditions

Coronary Artery Disease

Interventions

Cilostazol eluting stent system (CES-1)

DEVICE

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

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Coronary Artery Disease

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"Erectile Function After PCI in MI and Non-MI Patients"

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

"Erectile Function After PCI in MI and Non-MI Patients"

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