Clinical trial NCT01752127: COmparison of Xience PrimE Versus REsolute Integrity in Diabetes or Small Vessel Disease
Official title: Study for Investigate the Effectiveness and Safety of Resolute Integrity or Xience Prime in Diabetes or Small Vessels Lesion Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Angioplasty, Balloon, Coronary
Keywords: Drug-eluting stent
diabetes
small vessel disease
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: in-segment late lumen loss (mm)at 12month
timeFrame: 12month
Secondary outcomes:
measure: major adverse cardiac events(MACE) at 12month
timeFrame: 12month
measure: MACE at 24month
timeFrame: 24month
measure: procedure success rate
timeFrame: 1 day (after procedure)
Other outcomes:
Locations:
city: Jeon-Ju
country: Korea, Republic of
facility: Devision of cardiology, Chonbuk national university hospital
state: Chon-buk
Study officials:
References: