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| Sponsored by: |
Medical University of Vienna |
|---|---|
| Information provided by: | Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT00317265 |
Purpose
This is a randomized, prospective European Multicenter Study comparing complete arterial revascularization of the coronary arteries using arterial graft material exclusively and “conventional” coronary artery bypass surgery using the left internal thoracic artery as graft to the left anterior descending artery (LAD) and vein grafts to other vessels to be bypassed.
| Condition | Intervention |
|---|---|
|
Coronary Artery Disease |
Procedure: Coronary bypass surgery |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Complete Arterial Revascularization and Conventional Coronary Artery Surgery Study (CARACCASS)-European Multicenter Study |
| Estimated Enrollment: | 2000 |
| Study Start Date: | January 1999 |
| Estimated Study Completion Date: | January 2005 |
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 impact. Unfortunately angina returns in 10 to 20 percent of patients by five years and in up to 50 percent at 10 years primarily because of graft failure and progression of atherosclerosis in the native coronary arteries. Serial angiography reveals that 15-30 percent of vein grafts are stenosed at one year and that nearly 50 percent are occluded at ten years. Recurrence of angina is associated with an increased risk of late myocardial infarction and reoperation. Reoperations after cardiac surgery carry a significantly increased risk of morbidity and mortality due to increased patient age, progression of coronary atherosclerosis, frequently reduced left ventricular function and technical difficulties.
Thus prevention of restenosis by medical and surgical means is of eminent importance.The use of the IMA as a graft to the LAD is proven to reduce long-term mortality in patients after CABG throughout a 15 year follow-up period in all age groups. This data and the further improved survival with bilateral IMA grafting suggested by some have increased the interest of the surgical community in total arterial revascularization using both IMAs and various other arterial conduits. However to date there is no conclusive data demonstrating a clinical benefit of total arterial revascularization.Reports available on complete arterial revascularisation are either single institution / single surgeon, retrospective or non - randomized. Data on which we base our daily decision making is by and large from a different surgical period with different techniques used. Improved understanding of the pathogenic processes leading to graft occlusion have led to more rigorous use of antiplatelet drugs and lipid lowering which may significantly improve vein graft patency rates and slow or halt progression of native coronary artery atherosclerosis in the future.
The scientific hypotheses underlying this randomized multicenter trial are:
Eligibility| Ages Eligible for Study: | 18 Years to 71 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Austria | |
| Dept Cardiothoracic Surgery, Medical Univ. of Vienna | |
| Vienna, Austria, A-1090 | |
| Dept. of Surgery I, AKH Linz | |
| Linz, Austria, 4020 | |
| Czech Republic | |
| Clinic for Cardiovascular Surgery, IKEM | |
| Prague, Czech Republic, 14000 | |
| Kardiochirurgie, Nemocnice Podlesi | |
| Trinec, Czech Republic, 73961 | |
| Germany | |
| Dept of Cardiothoracic and Vascular Surgery, J-W-Goethe University | |
| Frankfurt, Germany, 60590 | |
| Dept.of Cardiac Surg, Ruhr University | |
| Bochum, Germany, 44789 | |
| Kerckhoff-Klinik | |
| Bad Nauheim, Germany | |
| HKZ Rotenburg | |
| Rothenburg an der Fulda, Germany, 36199 | |
| Norway | |
| Hjerteklinikken St. Elisabeth, Regionsykehuset Trondheim | |
| Trondheim, Norway, 7018 | |
| Poland | |
| Dept Cardiothoracic Surg, Univ. of Gdansk | |
| Gdansk, Poland, 80211 | |
| Spain | |
| Dept of Cardiovasc Surg, Hospital Clinico, University of Barcelona | |
| Barcelona, Spain, 08036 | |
| Dept of Cardiac Surg, Hospital de Cruces | |
| Bilbao, Spain, 48190 | |
| Dept. of Cardiovascular Surgery, University of Salamanca | |
| Salamanca, Spain | |
| Sweden | |
| Department of Cardiothoracic Surgery, University Hospital | |
| Linköping, Sweden, 58185 | |
| Principal Investigator: | Paul Simon, MD | Dept. of Cardiothoracic Surgery, Medical Univ. of Vienna |
More Information
| Study ID Numbers: | EK NR-348/98 |
| Study First Received: | April 20, 2006 |
| Last Updated: | October 12, 2006 |
| ClinicalTrials.gov Identifier: | NCT00317265 History of Changes |
| Health Authority: | Austria: Ethikkommission |
|
coronary artery disease coronary bypass surgery complete arterial coronary surgery internal mammary artery |
|
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
|
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |