None listed
Conditions
Interventions
Medical Device : All consecutive patients with angiographically defined significant coronary artery disease and amenable for percutaneous coronary intervention(PCI) should be screened and considered f
30%
residual stenosis, wherea
Sponsors
Chungnam National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Major adverse cardiac event, defined as a composite of all-cause death, myocardial infarction, any repeat revascularization;Death from any causes;Cardiovascular death;Myocardial infarction: target lesion related vs. non-target lesion related; target vessel-related vs. non-target vessel related; Q-wave vs. non-Q wave; periprocedural vs. spontaneous myocardial infarction;Repeat revascularization: target vessel revascularization vs. non-target vessel revascularization; target lesion revascularization vs. non-target lesion revascularization; any repeat revascularization; ischemia-driven revascularization vs. non-ischemia driven revascularization;Stent thrombosis: According to ARC (Academic Research Consortium Definitions): -Definite, probable, possible -Acute, subacute, late, very late;In-segment and in-stent luminal loss on 9-month follow up coronary angiography;Cerebrovascular accident (CVA);Major adverse cardiac and cerebrovascular event (MACCE), defined as a composite of all-cause death, myocardial infarction, any repeat revascularization;Combinations of all-cause death with other components of MACCE;Combinations of cardiovascular death with components of MACCE other than all-cause death;Procedural success (defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization). | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung-eun Choi
Chungnam National University Hospital
Outcome results
None listed