Angioplasty, Balloon, Coronary
Conditions
Keywords
Drug-eluting stent, diabetes, small vessel disease
Brief summary
The newer generation ZES (Medtronic, Minneapolis, MN, Resolute Integrity) and EES (Abbott Vascular, Abbott Park, Illinois, Xience Prime) were introduced to South Korea. Although these are thought to be superior in effect and stability compared to ZES and EES of previous generation, there are few clinical data regarding the high risk groups of diabetes patients or small vessels lesion. Moreover, looking at the 8.3% of restenosis in Resolute All Comer study (23% diabetes), the investigators could not know the outcome in high risk patients such as diabetes or small vessels lesion. Therefore, the aim of this study is to investigate the effectiveness and safety of Resolute Integrity or Xience Prime in diabetes or small vessels lesion patients.
Interventions
PROCEDUREpercutaneous coronary intervention using drug eluting stent
1\. Intracoronary stenting 1. The procedure could be conducted via brachial, radial or femoral approaches. 2. There are no restrictions regarding lesion's length or diameter. For long lesions, overlapping of several stents would be allowed but only allocated type of stents should be used. 3. When several lesions are included in the study of a patient, each lesion may be allocated in different groups. Only if deployment of the allocated stent is not possible, crossing to other stent would be allowed. 4. Direct stenting or bifurcation stenting is allowed. 5. Predilation before stenting, IVUS examination, and administration of glycoprotein IIb/IIIa inhibitor would be determined by investigator.
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 years 2. Patients requiring stent procedure (visual diameter stenosis ≥ 50%) 3. Stable angina with evidence of myocardial ischemia, acute coronary syndrome(ST segment elevation, non-ST segment elevation acute myocardial infarction, and unstable angina) 4. Patients diagnosed of type 2 diabetes or small vessel disease 5. Patients willing to participate in the study through written consent
Exclusion criteria
1. Those hypersensitive to or abstaining from heparin, aspirin, clopidogrel, contrast medium, zotarolimus, or everolimus. 2. Pregnant women or those having future plans for pregnancy. 3. Those having hemorrhagic disease or blood-clotting disorders (including heparin-induced thrombocytopenia), or those rejecting blood transfusion. 4. Those having medical history of digestive and urinary system bleeding during the last 3 months, or who have received major surgery within 2 months. 5. Those with thrombocytopenia (\< 100,000/mm3) or hemoglobin 10.0 g/dL or less. 6. Those planning a surgery that requires the discontinuation of antiplatelet drugs within next 12 months (especially, thienopyridines type). 7. When the remaining survival period is expected to be less than 1 year. 8. Restenosis lesion 9. Left main coronary artery lesion 10. Saphenous vein graft stenosis lesion 11. Left ventricular ejection fraction \< 30% 12. Cardiac shock 13. Those with liver function failure: When liver enzyme level (ALT) is 3 times the normal upper limit. 14. Type I diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| in-segment late lumen loss (mm)at 12month | 12month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| major adverse cardiac events(MACE) at 12month | 12month | 1\) Occurrence of major adverse cardiac events (MACE) during 12 months * Cardiac death * Target vessel related myocardial infarction * Ischemia driven Target Vessel Revascularization (TVR) * Ischemia driven Target Lesion Revascularization (TLR) * Definite / probable stent thrombosis by ARC definition |
| MACE at 24month | 24month | 2\) Occurrence of major adverse cardiac events (MACE) during 24 months * Cardiac death * Target vessel related myocardial infarction * Ischemia driven Target Vessel Revascularization (TVR) * Ischemia driven Target Lesion Revascularization (TLR) * Definite / probable stent thrombosis by ARC definition |
| procedure success rate | 1 day (after procedure) | Procedure success rate proportion of investigational stent deployed successfully without chage to other stent |
Countries
South Korea
Contacts
Primary ContactLae young Jung, fellow
Outcome results
None listed