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

This study is currently recruiting participants.
Verified December 2012 by Chonbuk National University Hospital
Sponsor:
Information provided by (Responsible Party):
Lae Young Jung, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01752127
First received: December 2, 2012
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Angioplasty, Balloon, Coronary
 Procedure: percutaneous coronary intervention using drug eluting stent
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Study for Investigate the Effectiveness and Safety of Resolute Integrity or Xience Prime in Diabetes or Small Vessels Lesion Patients

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Diabetes
U.S. FDA Resources

Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • in-segment late lumen loss (mm)at 12month [ Time Frame: 12month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • major adverse cardiac events(MACE) at 12month [ Time Frame: 12month ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 24month ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 1 day (after procedure) ] [ Designated as safety issue: No ]
    Procedure success rate proportion of investigational stent deployed successfully without chage to other stent


Estimated Enrollment: 600
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DM arms
comparison of two different stents(Xience prime and Resolute integrity)
 Procedure: 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.
Other Name: using two drug eluting stent(XIENCE PRIME and RESOLUTE INTEGRITY)
Active Comparator: Small vessel arms
comparison of two different stents(Xience prime and Resolute integrity)
 Procedure: 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.
Other Name: using two drug eluting stent(XIENCE PRIME and RESOLUTE INTEGRITY)

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752127

Contacts
Contact: Lae young Jung, fellow 82-63-250-2204 youngjoin@naver.com

Locations
Korea, Republic of
Devision of cardiology, Chonbuk national university hospital Recruiting
Jeon-Ju, Chon-buk, Korea, Republic of
Contact: Lae young Jung, fellow     82-63-250-2204     young@naver.com    
Sponsors and Collaborators
Chonbuk National University Hospital
  More Information

No publications provided

Responsible Party: Lae Young Jung, Doctor, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01752127     History of Changes
Other Study ID Numbers: The COPERES trial
Study First Received: December 2, 2012
Last Updated: December 18, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Chonbuk National University Hospital:
Drug-eluting stent
diabetes
small vessel disease

ClinicalTrials.gov processed this record on May 21, 2013