COmparison of Xience PrimE Versus REsolute Integrity in Diabetes or Small Vessel Disease

Phase 3

• Conditions: Angioplasty, Balloon, Coronary
• Interventions: Procedure: percutaneous coronary intervention using drug eluting stent

• Registration Number: NCT01752127
• Lead Sponsor: Chonbuk National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Status Verified: 2012-12
• Study First Submitted: 2012-12-02
• Study First Submitted QC: 2012-12-18
• Last Update Submitted: 2012-12-18
• Study First Posted: 2012-12-19
• Last Update Posted: 2012-12-19
• Primary Completion: 2013-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DM arms	percutaneous coronary intervention using drug eluting stent	comparison of two different stents(Xience prime and Resolute integrity)
Small vessel arms	percutaneous coronary intervention using drug eluting stent	comparison of two different stents(Xience prime and Resolute integrity)

Primary Outcome Measures

Name	Time	Method
in-segment late lumen loss (mm)at 12month	12month

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Devision of cardiology, Chonbuk national university hospital; 🇰🇷 Jeon-Ju, Chon-buk, Korea, Republic of