Status:
COMPLETED
Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease
Lead Sponsor:
Seung-Jung Park
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of the PRE-COMBAT trial is: To establish the safety and effectiveness of coronary stenting with the sirolimus-eluting balloon expandable stent (Cordis Johnson \& Johnson, Warren...
Detailed Description
Despite bypass surgery has been considered as the standard strategy for the treatment of unprotected left main coronary artery (LMCA) lesions, several studies have demonstrated that percutaneous coron...
Eligibility Criteria
Inclusion
- 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 bypass surgery
- 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.
Exclusion
- The patient has a known hypersensitivity or contraindication to any of the following medications:
- Heparin
- Aspirin
- Both Clopidogrel and TIclopidine
- Sirolimus, 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) Sirolimus, 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
- Any disabled stroke with neurological deficit or any cerebrovascular accident within 6 months
- Creatinine level \> 2.0mg/dL or dependence on dialysis.
- Severe hepatic dysfunction (AST and ALT \> 3 times upper normal reference values).
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- Current known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL.
- An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 1 year post enrollment.
- 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).
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- Subject unable or unwilling to follow-up with visits required by protocol
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
1454 Patients enrolled
Trial Details
Trial ID
NCT00422968
Start Date
March 1 2005
End Date
December 1 2013
Last Update
May 1 2014
Active Locations (13)
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1
Daegu Catholic University Medical Center
Daegu, South Korea
2
Chungnam National University Hospital
Daejeon, South Korea
3
Chonnam National University Hospital
Gwangju, South Korea
4
Seoul National University Bundang Hospital
Seongnam, South Korea