Evaluation of Outcomes of EES Implantation for Unprotected Left Main Coronary Artery Stenosis (PRE-COMBAT 2)
NCT ID: NCT01348022
Last Updated: 2015-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
397 participants
OBSERVATIONAL
2009-08-31
2015-09-30
Brief Summary
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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
Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Xience V stent
unprotected Left Main Coronary Artery stenting treated with Xience V stent
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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CardioVascular Research Foundation, Korea
OTHER
Abbott
INDUSTRY
Seung-Jung Park
OTHER
Responsible Party
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Seung-Jung Park
M.D., Ph.D.,Professor of Medicine Asan Medical Center, University of Ulsan, College of Medicine
Principal Investigators
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Seung-Jung Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Soon Chun Hyang University Hospital Bucheon
Bucheon-si, , South Korea
Kangwon National University Hospital
Chuncheon, , South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, , South Korea
Gangneung Asan Hospital
Gangneung, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Kwangju Christian Hospital
Kwangju, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , South Korea
Veterans Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Countries
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References
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Kim YH, Park DW, Ahn JM, Yun SC, Song HG, Lee JY, Kim WJ, Kang SJ, Lee SW, Lee CW, Park SW, Jang Y, Jeong MH, Kim HS, Hur SH, Rha SW, Lim DS, Her SH, Seung KB, Seong IW, Park SJ; PRECOMBAT-2 Investigators. Everolimus-eluting stent implantation for unprotected left main coronary artery stenosis. The PRECOMBAT-2 (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) study. JACC Cardiovasc Interv. 2012 Jul;5(7):708-17. doi: 10.1016/j.jcin.2012.05.002.
Other Identifiers
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2009-0361
Identifier Type: -
Identifier Source: org_study_id