Coronary Artery DiseaseNCT03189641
Clinical Trial of Cilostazol Eluting Stent System (CES-1) in De Novo Coronary Artery Lesions
A study testing Cilostazol eluting stent system (CES-1) in people with Coronary Artery Disease, run by JIMRO Co., Ltd. at 6 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cilostazol eluting stent system (CES-1)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesJapan
- Study dates
- 31 May 2017to 26 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- <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
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- 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
Who cannot join
- <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).
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Mitsui Memorial Hospital
Chiyoda City, Tokyo
Tokai University Hospital
Isehara, Kanagawa
Kitasato University Hospital
Sagamihara, Kanagawa
Teikyo University Hospital
tabashi City, Tokyo
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Kanagawa
Showa University Fujigaoka Hospital
Yokohama, Kanagawa
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Cilostazol eluting stent system (CES-1)
- Keywords
- Drug eluting stents, Coronary artery disease, Coronary artery stenosis, Myocardial ischemia, Angioplasty
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilostazol eluting stent system (CES-1)Device
Implantation of drug eluting stent
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol eluting stent system (CES-1) | Experimental | Not described Receives: Device: Cilostazol eluting stent system (CES-1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-segment late lumen loss as measured by quantitative coronary angiography (QCA)
Measured: 9 months
Secondary outcomes (12)
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.
Measured: 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.
Measured: At the time of hospital discharge, expected 1or 2 days after of procedure
Target Lesion Failure (TLF)
Measured: 9 Months
Target Vessel Failure (TVF)
Measured: 9 Months
Stent thrombosis
Measured: 9 Months
Patient Oriented Composite End point (POCE)
POCE: All cause death, all myocardial infarction, or all revascularization with ischemia
Measured: 9 Months
In-stent and in-segment %diameter stenosis (%DS) as measured by QCA
Measured: 9 Months
In-stent and in-segment %Angiographic Binary Restenosis (%ABR)
Measured: 9 Months
Neointima volume as measured by OCT/OFDI
Measured: 9 Months
%Volume obstruction as measured by OCT/OFDI
Measured: 9 Months
%Incomplete stent apposition (%ISA) as measured by OCT/OFDI
Measured: 9 Months
%Covered strut as measured by OCT/OFDI
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start31 May 2017
- Primary completion27 Mar 2020
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- JIMRO Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189641
- Sponsor's protocol ID
- JD-001
- Status last verified
- Mar 2025
- First submitted
- 13 Jun 2017
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Trial of Cilostazol Eluting Stent System (CES-1) in De Novo Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT03189641
- Acronym / sponsor ID
- JD-001
- Conditions
- Coronary Artery Disease
- Keywords
- Drug eluting stents, Coronary artery disease, Coronary artery stenosis, Myocardial ischemia, Angioplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- JIMRO Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 May 2017 (actual)
- Primary completion
- 27 Mar 2020 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cilostazol eluting stent system (CES-1) | Experimental | Device: Cilostazol eluting stent system (CES-1) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- <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>
Key exclusion criteria (26 listed)
- <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.
- Patients who cannot be given emergency coronary artery bypass grafting (CABG).
- Patients who cannot be administered antiplatelet drugs. The following cases are conceivable.
- Bleeding tendency due to hemorrhagic diathesis or blood coagulation disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cilostazol eluting stent system (CES-1)Implantation of drug eluting stent | Device | Cilostazol eluting stent system (CES-1) |
Primary outcome
In-segment late lumen loss as measured by quantitative coronary angiography (QCA)
Time frame: 9 months
12 secondary outcomes
Device Success rate
Time frame: Immediate post-procedure
Procedure success rate
Time frame: At the time of hospital discharge, expected 1or 2 days after of procedure
Target Lesion Failure (TLF)
Time frame: 9 Months
Target Vessel Failure (TVF)
Time frame: 9 Months
Stent thrombosis
Time frame: 9 Months
Patient Oriented Composite End point (POCE)
Time frame: 9 Months
In-stent and in-segment %diameter stenosis (%DS) as measured by QCA
Time frame: 9 Months
In-stent and in-segment %Angiographic Binary Restenosis (%ABR)
Time frame: 9 Months
Neointima volume as measured by OCT/OFDI
Time frame: 9 Months
%Volume obstruction as measured by OCT/OFDI
Time frame: 9 Months
%Incomplete stent apposition (%ISA) as measured by OCT/OFDI
Time frame: 9 Months
%Covered strut as measured by OCT/OFDI
Time frame: 9 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cilostazol eluting stent system (CES-1) in people with Coronary Artery Disease, run by JIMRO Co., Ltd. at 6 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-segment late lumen loss as measured by quantitative coronary angiography (QCA) (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.