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

NCT01752127 | Unknown Phase 3

• 1 other identifier: The COPERES trial
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• in-segment late lumen loss (mm)at 12month

  12month

Secondary Outcomes (3)

• major adverse cardiac events(MACE) at 12month

  12month

• MACE at 24month

  24month

• procedure success rate

  1 day (after procedure)

Study Arms (2)

DM arms

ACTIVE COMPARATOR

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

Procedure: percutaneous coronary intervention using drug eluting stent

Small vessel arms

ACTIVE COMPARATOR

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

Procedure: percutaneous coronary intervention using drug eluting stent

Interventions

percutaneous coronary intervention using drug eluting stent 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.

Also known as: using two drug eluting stent(XIENCE PRIME and RESOLUTE INTEGRITY)

DM arms; Small vessel arms

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Patients requiring stent procedure (visual diameter stenosis ≥ 50%)
• Stable angina with evidence of myocardial ischemia, acute coronary syndrome(ST segment elevation, non-ST segment elevation acute myocardial infarction, and unstable angina)
• Patients diagnosed of type 2 diabetes or small vessel disease
• Patients willing to participate in the study through written consent

You may not qualify if:

• Those hypersensitive to or abstaining from heparin, aspirin, clopidogrel, contrast medium, zotarolimus, or everolimus.
• Pregnant women or those having future plans for pregnancy.
• Those having hemorrhagic disease or blood-clotting disorders (including heparin-induced thrombocytopenia), or those rejecting blood transfusion.
• Those having medical history of digestive and urinary system bleeding during the last 3 months, or who have received major surgery within 2 months.
• Those with thrombocytopenia (\< 100,000/mm3) or hemoglobin 10.0 g/dL or less.
• Those planning a surgery that requires the discontinuation of antiplatelet drugs within next 12 months (especially, thienopyridines type).
• When the remaining survival period is expected to be less than 1 year.
• Restenosis lesion
• Left main coronary artery lesion
• Saphenous vein graft stenosis lesion
• Left ventricular ejection fraction \< 30%
• Cardiac shock
• Those with liver function failure: When liver enzyme level (ALT) is 3 times the normal upper limit.
• Type I diabetes

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Devision of cardiology, Chonbuk national university hospital

Jeonju, Chon-buk, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Lae young Jung, fellow

CONTACT

82-63-250-2204; youngjoin@naver.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 2, 2012
• First Posted: December 19, 2012
• Study Start: July 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 19, 2012

Record last verified: 2012-12

Locations

KR (1)