Evaluation of Outcomes of EES Implantation for Unprotected Left Main Coronary Artery Stenosis (PRE-COMBAT 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01348022
Recruitment Status : Completed
First Posted : May 5, 2011
Last Update Posted : November 20, 2015
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea

Brief Summary:

This study is a multicenter, open label, prospective, single arm trial

Single arm group; following angiography, eligible patients with unprotected LMCA stenosis >50% by visual estimation, which is equally treatable by the both treatment strategy (EES stenting or CABG), will be treated with EES

Condition or disease
Coronary Artery Disease

Detailed Description:

The primary objective of the PRECOMBAT-2 trial is to establish the safety and effectiveness of coronary stenting with the everolimus-eluting Xience V stent (EES) compared with the historical control (PRE-COMBAT-1) of bypass surgery and sirolimus-eluting stent (SES) for the treatment of an unprotected LMCA stenosis. The primary alternative hypothesis is that the experimental starategy (coronary stenting with the everolimus-eluting stents) is not inferior to the standard strategy (CABG) or SES.

All consecutive patients with unprotected LMCA diseases at participating centers, who are treated with Xience V stent, will be evaluated for the entry into the study.

Study Type : Observational
Actual Enrollment : 397 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Outcomes of Everolimus-Eluting Stent (XIENCE V) Implantation for Unprotected Left Main Coronary Artery Stenosis: Multicenter Trial
Study Start Date : August 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : September 2015

Xience V stent
unprotected Left Main Coronary Artery stenting treated with Xience V stent

Primary Outcome Measures :
  1. MACCE free survival [ Time Frame: at 2 year ]
    Death (all-cause mortality) Cerebrovascular accident Non-fatal myocardial infarction (Q wave and non-Q wave) Ischemia-driven target vessel revascularization either percutaneous or surgical treatment

Secondary Outcome Measures :
  1. Death(all cause and cardiac) [ Time Frame: 5 years ]
  2. Myocardial Infarction [ Time Frame: 5 years ]
  3. Cerebrovascular accident [ Time Frame: 5 years ]
  4. Target vessel revascularization [ Time Frame: 5 years ]
  5. Target lesion revascularization [ Time Frame: 5 years ]
  6. Stent thrombosis [ Time Frame: 5 years ]
  7. Binary restenosis in both in-stent and in-segment [ Time Frame: 9 months ]
    angiographic follow-up

  8. Late luminal loss in both in-stent and in-segment [ Time Frame: 9 months ]
    angiographic follow-up

  9. pattern of restenosis [ Time Frame: 9 months ]
    angiographic follow-up

  10. Angina status [ Time Frame: 5 years ]
  11. Re-hospitalization with a cardiac cause [ Time Frame: 5 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Coronary artery disease requiring drug eluting stents

Inclusion Criteria:

  1. The patient must be at least 18 years of age.
  2. Significant de novo left main stenosis (>50% by visual estimation) with or without any additional target lesions (>70% by visual estimation)
  3. Left main lesion and lesions outside LMCA (if present) potentially equally treatable with coronary stenting and CABG
  4. Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia
  5. The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

  1. The patient has a known hypersensitivity or contraindication to any of the following medications:

    • Heparin
    • Aspirin
    • Both Clopidogrel and TIclopidine
    • Everolimus, paclitaxel, ABT 578
    • Stainless steel and/or
    • Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
  2. Systemic (intravenous) Everolimus, paclitaxel or ABT-578 use within 12 months.
  3. Any previous PCI within 1 year
  4. Previous bypass surgery
  5. Any previous PCI of a LMCA or ostial left circumflex artery or ostial left anterior descending artery lesion within 1 year
  6. Intention to treat more than one totally occluded major epicardial vessel
  7. Acute MI patients within 1 week
  8. Patients with EF<30%.
  9. Patients with cardiogenic shock
  10. Any disabled stroke with neurological deficit or any cerebrovascular accident within 6 months
  11. Creatinine level 2.0mg/dL or dependence on dialysis.
  12. Severe hepatic dysfunction (AST and ALT 3 times upper normal reference values).
  13. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
  14. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
  15. Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
  16. An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 1 year post enrollment.
  17. Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  18. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  19. Subject unable or unwilling to follow-up with visits required by protocol
  20. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01348022

Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
Bucheon, Korea, Republic of
Kangwon National University Hospital
Chuncheon, Korea, Republic of
Daegu Catholic University Medical Center
Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, Korea, Republic of
Gangneung Asan Hospital
Gangneung, Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
Kwangju Christian Hospital
Kwangju, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Korea University Anam Hospital
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University hospital
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, Korea, Republic of
Veterans Hospital
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Seung-Jung Park, M.D., Ph.D.,Professor of Medicine Asan Medical Center, University of Ulsan, College of Medicine, CardioVascular Research Foundation, Korea Identifier: NCT01348022     History of Changes
Other Study ID Numbers: 2009-0361
First Posted: May 5, 2011    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases