Status:
TERMINATED
Coronary Bypass Surgery Trial: Complete Arterial Revascularization and Conventional Coronary Artery Surgery
Lead Sponsor:
Medical University of Vienna
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-71 years
Phase:
NA
Brief Summary
This is a randomized, prospective European Multicenter Study comparing complete arterial revascularization of the coronary arteries using arterial graft material exclusively and "conventional" coronar...
Detailed Description
Coronary artery surgery effectively relieves angina and prolongs life in certain patient subsets. It is the most frequently performed major surgical procedure and therefore has profound economical imp...
Eligibility Criteria
Inclusion
- Patient eligible for surgical myocardial revascularization
- Age 70 years or less
- Triple vessel coronary disease with significant coronary artery stenosis defined as a stenosis of at least 50% in luminal diameter
- Patients with stable angina pectoris (Canadian Cardiovascular Society 1, 2, 3, or 4) or unstable angina pectoris (Braunwald Classification 1b, 2b, 3b) or proven silent myocardial ischemia.
Exclusion
- No informed consent
- Age \> 65 years
- Participation in another study with any investigational drug or coronary revascularization procedure
- When follow up over a period of five years is difficult or unlikely
- Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer)
- One or two vessel coronary disease and isolated left main stenosis
- Estimated left ventricular ejection fraction \< 25%
- Myocardial infarction within seven days
- Need for concomitant major cardiac or non-cardiac surgery (e.g. valve surgery, left ventricular aneurysm, aortic aneurysm, carotid artery desobliteration, etc.)
- Redo-cardiac surgery
- Presence of the combination of insulin dependent diabetes mellitus and chronic obstructive pulmonary disease requiring therapy
- Renal insufficiency requiring dialysis
- Presence of the combination of severe adiposity and insulin dependent diabetes mellitus
- Presence of the combination of severe adiposity and chronic obstructive pulmonary disease requiring therapy
- Severe hepatic disease
- Emergent operation for coronary artery disease with signs of ischemia (e.g. failed PTCA, ongoing myocardial infarction)
- Unstable angina pectoris Class A and C according to Braunwald classification (i.e. secondary unstable angina and postinfarction unstable angina within one week after acute MI)
- Inadequate quality of saphenous vein material
- Inadequate quality or number of arterial conduits to achieve complete revascularization likely (e.g. chest irradiation, major abdominal surgery)
- Recent (\< 2weeks) cerebrovascular event (TIA, RIND, stroke)
Key Trial Info
Start Date :
January 1 1999
Trial Type :
INTERVENTIONAL
End Date :
January 1 2005
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT00317265
Start Date
January 1 1999
End Date
January 1 2005
Last Update
October 13 2006
Active Locations (14)
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1
Dept. of Surgery I, AKH Linz
Linz, Austria, 4020
2
Dept Cardiothoracic Surgery, Medical Univ. of Vienna
Vienna, Austria, A-1090
3
Clinic for Cardiovascular Surgery, IKEM
Prague, Czechia, 14000
4
Kardiochirurgie, Nemocnice Podlesi
Třinec, Czechia, 73961