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

Angioplasty, Balloon, Coronary Clinical Trial

— COPERES  

Official title:

Study for Investigate the Effectiveness and Safety of Resolute Integrity or Xience Prime in Diabetes or Small Vessels Lesion Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01752127
• Other study ID #: The COPERES trial
• Status: Recruiting
• Phase: Phase 3
• First received: December 2, 2012
• Last updated: December 18, 2012
• Start date: July 2011
• Est. completion date: July 2013

Study information

• Verified date: December 2012
• Source: Chonbuk National University Hospital
• Contact: Lae young Jung, fellow
• Phone: 82-63-250-2204
• Email: youngjoin[@]naver.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioplasty, Balloon, Coronary

Intervention

Procedure:
• percutaneous coronary intervention using drug eluting stent
1. Intracoronary stenting The procedure could be conducted via brachial, radial or femoral approaches. 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. 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. Direct stenting or bifurcation stenting is allowed. Predilation before stenting, IVUS examination, and administration of glycoprotein IIb/IIIa inhibitor would be determined by investigator.

Locations

Country	Name	City	State
Korea, Republic of	Devision of cardiology, Chonbuk national university hospital	Jeon-Ju	Chon-buk

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in-segment late lumen loss (mm)at 12month		12month	Yes
Secondary	major adverse cardiac events(MACE) at 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	12month	Yes
Secondary	MACE at 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	24month	Yes
Secondary	procedure success rate	Procedure success rate proportion of investigational stent deployed successfully without chage to other stent	1 day (after procedure)	No