Evaluation of Outcomes of EES Implantation for Unprotected Left Main Coronary Artery Stenosis (PRE-COMBAT 2)
Prospective Evaluation of Outcomes of Everolimus-Eluting Stent (XIENCE V) Implantation for Unprotected Left Main Coronary Artery Stenosis: Multicenter Trial
1 other identifier
observational
397
1 country
21
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2009
Longer than P75 for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 22, 2011
CompletedFirst Posted
Study publicly available on registry
May 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedNovember 20, 2015
November 1, 2015
3.3 years
April 22, 2011
November 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
MACCE free survival
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
at 2 year
Secondary Outcomes (11)
Death(all cause and cardiac)
5 years
Myocardial Infarction
5 years
Cerebrovascular accident
5 years
Target vessel revascularization
5 years
Target lesion revascularization
5 years
- +6 more secondary outcomes
Study Arms (1)
Xience V stent
unprotected Left Main Coronary Artery stenting treated with Xience V stent
Eligibility Criteria
Coronary artery disease requiring drug eluting stents
You may qualify if:
- The patient must be at least 18 years of age.
- Significant de novo left main stenosis (\>50% by visual estimation) with or without any additional target lesions (\>70% by visual estimation)
- Left main lesion and lesions outside LMCA (if present) potentially equally treatable with coronary stenting and CABG
- 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
- 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.
You may not qualify if:
- 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).
- Systemic (intravenous) Everolimus, paclitaxel or ABT-578 use within 12 months.
- Any previous PCI within 1 year
- Previous bypass surgery
- Any previous PCI of a LMCA or ostial left circumflex artery or ostial left anterior descending artery lesion within 1 year
- Intention to treat more than one totally occluded major epicardial vessel
- Acute MI patients within 1 week
- Patients with EF\<30%.
- Patients with cardiogenic shock
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung-Jung Parklead
- CardioVascular Research Foundation, Koreacollaborator
- Abbottcollaborator
Study Sites (21)
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, 138-736, 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
Related Publications (1)
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.
PMID: 22814775DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Jung Park, MD, PhD
Asan Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- M.D., Ph.D.,Professor of Medicine Asan Medical Center, University of Ulsan, College of Medicine
Study Record Dates
First Submitted
April 22, 2011
First Posted
May 5, 2011
Study Start
August 1, 2009
Primary Completion
December 1, 2012
Study Completion
September 1, 2015
Last Updated
November 20, 2015
Record last verified: 2015-11