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 range20 Years

SexALL

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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.
✕. 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.

What they're measuring

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

Timeframe: 9 months

Trial details

NCT IDNCT03189641

SponsorJIMRO Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-03-27

View on ClinicalTrials.gov More Coronary Artery Disease trials