Clinical Trial of Cilostazol Eluting Stent System (CES-1) in De Novo Coronary Artery Lesions (NCT03189641) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial of Cilostazol Eluting Stent System (CES-1) in De Novo Coronary Artery Lesions
Japan30 participantsStarted 2017-05-31
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
. 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
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
In-segment late lumen loss as measured by quantitative coronary angiography (QCA)
. 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.