Coronary Bypass Surgery Trial: Complete Arterial Revascularization and Conventional Coronary Artery Surgery

October 12, 2006 updated by: Medical University of Vienna

Complete Arterial Revascularization and Conventional Coronary Artery Surgery Study (CARACCASS)-European Multicenter Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 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:

  1. With respect to the primary outcome variable "total mortality" complete arterial revascularisation does not cause a significantly higher mortality over 5 years of follow-up (as compared to conventional coronary artery surgery) i.e. non-inferiority due to increased tecnical complexity of the surgical procedure.
  2. In terms of the combined secondary outcome variable "cardiac death, nonfatal myocardial infarction and re-revascularisation (PTCA or CABG)" and additional outcome variables "freedom from angina, functional status and quality of life" complete arterial revascularisation shows a clear benefit.

Study Type

Interventional

Enrollment

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4020
        • Dept. of Surgery I, AKH Linz
      • Vienna, Austria, A-1090
        • Dept Cardiothoracic Surgery, Medical Univ. of Vienna
  • Czech Republic
      • Prague, Czech Republic, 14000
        • Clinic for Cardiovascular Surgery, IKEM
      • Trinec, Czech Republic, 73961
        • Kardiochirurgie, Nemocnice Podlesi
  • Germany
      • Bad Nauheim, Germany
        • Kerckhoff-Klinik
      • Bochum, Germany, 44789
        • Dept.of Cardiac Surg, Ruhr University
      • Frankfurt, Germany, 60590
        • Dept of Cardiothoracic and Vascular Surgery, J-W-Goethe University
      • Rothenburg an der Fulda, Germany, 36199
        • HKZ Rotenburg
  • Norway
      • Trondheim, Norway, 7018
        • Hjerteklinikken St. Elisabeth, Regionsykehuset Trondheim
  • Poland
      • Gdansk, Poland, 80211
        • Dept Cardiothoracic Surg, Univ. of Gdansk
  • Spain
      • Barcelona, Spain, 08036
        • Dept of Cardiovasc Surg, Hospital Clinico, University of Barcelona
      • Bilbao, Spain, 48190
        • Dept of Cardiac Surg, Hospital de Cruces
      • Salamanca, Spain
        • Dept. of Cardiovascular Surgery, University of Salamanca
  • Sweden
      • Linköping, Sweden, 58185
        • Department of Cardiothoracic Surgery, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient eligible for surgical myocardial revascularization
  2. Age 70 years or less
  3. Triple vessel coronary disease with significant coronary artery stenosis defined as a stenosis of at least 50% in luminal diameter
  4. 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 Criteria:

  1. No informed consent
  2. Age > 65 years
  3. Participation in another study with any investigational drug or coronary revascularization procedure
  4. When follow up over a period of five years is difficult or unlikely
  5. Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer)
  6. One or two vessel coronary disease and isolated left main stenosis
  7. Estimated left ventricular ejection fraction < 25%
  8. Myocardial infarction within seven days
  9. Need for concomitant major cardiac or non-cardiac surgery (e.g. valve surgery, left ventricular aneurysm, aortic aneurysm, carotid artery desobliteration, etc.)
  10. Redo-cardiac surgery
  11. Presence of the combination of insulin dependent diabetes mellitus and chronic obstructive pulmonary disease requiring therapy
  12. Renal insufficiency requiring dialysis
  13. Presence of the combination of severe adiposity and insulin dependent diabetes mellitus
  14. Presence of the combination of severe adiposity and chronic obstructive pulmonary disease requiring therapy
  15. Severe hepatic disease
  16. Emergent operation for coronary artery disease with signs of ischemia (e.g. failed PTCA, ongoing myocardial infarction)
  17. 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)
  18. Inadequate quality of saphenous vein material
  19. Inadequate quality or number of arterial conduits to achieve complete revascularization likely (e.g. chest irradiation, major abdominal surgery)
  20. Recent (< 2weeks) cerebrovascular event (TIA, RIND, stroke)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
All cause mortality perioperatively, one year, five and ten years.

Secondary Outcome Measures

Outcome Measure
Combined cardiac death, non-fatal myocardial infarction and repeat revascularisation at one, five and ten years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Paul Simon, MD, Dept. of Cardiothoracic Surgery, Medical Univ. of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1999

Study Completion

January 1, 2005

Study Registration Dates

First Submitted

April 20, 2006

First Submitted That Met QC Criteria

April 20, 2006

First Posted (Estimate)

April 24, 2006

Study Record Updates

Last Update Posted (Estimate)

October 13, 2006

Last Update Submitted That Met QC Criteria

October 12, 2006

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK NR-348/98

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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