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

NCT ID: NCT01752127

Last Updated: 2012-12-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-07-31

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.

Conditions

Angioplasty, Balloon, Coronary

Keywords

Drug-eluting stent; diabetes; small vessel disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DM arms

comparison of two different stents(Xience prime and Resolute integrity)

Group Type: ACTIVE_COMPARATOR

percutaneous coronary intervention using drug eluting stent

Intervention Type: PROCEDURE

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.

Small vessel arms

comparison of two different stents(Xience prime and Resolute integrity)

Group Type: ACTIVE_COMPARATOR

percutaneous coronary intervention using drug eluting stent

Intervention Type: PROCEDURE

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.

Interventions

percutaneous 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.

Intervention Type: PROCEDURE

Other Intervention Names

using two drug eluting stent(XIENCE PRIME and RESOLUTE INTEGRITY)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chonbuk National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lae Young Jung

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Devision of cardiology, Chonbuk national university hospital

Jeonju, Chon-buk, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Lae young Jung, fellow

Role: CONTACT

Phone: 82-63-250-2204

Email: youngjoin@naver.com

Facility Contacts

Lae young Jung, fellow

Role: primary

Other Identifiers

The COPERES trial

Identifier Type: -

Identifier Source: org_study_id