Multicenter, Randomized, Non-inferiority Study on Efficacy and Safety Between Everolimus-eluting Biodegradable Polymer Platinum Chromium and Durable Fluoropolymer Cobalt Chromium Stents in Patients with Diabetes Mellitus: Drug-Eluting Stenting for Patients with Diabetes mellitus II

Not Applicable

Conditions: Diseases of the circulatory system

Registration Number: KCT0002994

Lead Sponsor: Chungnam National University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 1268

Inclusion Criteria

1)Age 19 years or older, Diabetic patients
2)Coronary artery disease, amenable for percutaneous coronary intervention with Drug Eluting Stent
3)Symptom or sign, suggestive of myocardial ischemia (silent myocardial ischemia, chronic stable angina, unstable angina, non-ST elevation myocardial infarction)
4)Willing and able to provide informed written consent

Exclusion Criteria

1)ST-elevation myocardial infarction
2)Bypass graft lesion, or in-stent restenosis
3)left ventricle ejection fraction < 30%
4)Cardiogenic shock
5)Contraindication to or planned discontinuation of dual antiplatelet therapy within 1 year
6)Life expectancy <1 year
7)Planned cardiac surgery or planned major non cardiac surgery
8)Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study
9)Contraindication or hypersensitivity to contrast agents or heparin
10)Contraindication to everolimus

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary end-point of the DES-DIABETES II trial is the 1-year target-vessel failure (TVF) rate resulting from the randomization defined as:cardiovascular death, target vessel-related myocardial infarction, target vessel revascularization

Secondary Outcome Measures