Coronary Artery DiseaseNCT00317265
Coronary Bypass Surgery Trial: Complete Arterial Revascularization and Conventional Coronary Artery Surgery
A study testing Coronary bypass surgery in people with Coronary Artery Disease, run by Medical University of Vienna at 14 sites in 7 countries.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary bypass surgery
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 14 sitesin 7 countries
- Study dates
- Jan 1999to Jan 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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)
Trial locations and contacts
14 sites in 7 countries.
14 sites in 7 countries
Germany4 sites
Kerckhoff-Klinik
Bad Nauheim
Dept.of Cardiac Surg, Ruhr University
Bochum, 44789
Dept of Cardiothoracic and Vascular Surgery, J-W-Goethe University
Frankfurt, 60590
HKZ Rotenburg
Rothenburg An Der Fulda, 36199
Spain3 sites
Dept of Cardiovasc Surg, Hospital Clinico, University of Barcelona
Barcelona, 08036
Dept of Cardiac Surg, Hospital de Cruces
Bilbao, 48190
Dept. of Cardiovascular Surgery, University of Salamanca
Salamanca
Austria2 sites
Dept. of Surgery I, AKH Linz
Linz, 4020
Dept Cardiothoracic Surgery, Medical Univ. of Vienna
Vienna, A-1090
Czechia2 sites
Clinic for Cardiovascular Surgery, IKEM
Prague, 14000
Kardiochirurgie, Nemocnice Podlesi
Třinec, 73961
Norway1 site
Hjerteklinikken St. Elisabeth, Regionsykehuset Trondheim
Trondheim, 7018
Sweden1 site
Department of Cardiothoracic Surgery, University Hospital
Linköping, 58185
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary bypass surgery
- Keywords
- coronary artery disease, coronary bypass surgery, complete arterial coronary surgery, internal mammary artery
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary bypass surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality perioperatively, one year, five and ten years.
Secondary outcomes (1)
Combined cardiac death, non-fatal myocardial infarction and repeat revascularisation at one, five and ten years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2006 (estimated)
- Study startJan 1999
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Paul Simon, MD, Principal investigator, Dept. of Cardiothoracic Surgery, Medical Univ. of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317265
- Sponsor's protocol ID
- EK NR-348/98
- Status last verified
- Mar 2006
- First submitted
- 20 Apr 2006
- Last updated
- 13 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Arterial Revascularization and Conventional Coronary Artery Surgery Study (CARACCASS)-European Multicenter Study
- ClinicalTrials.gov ID
- NCT00317265
- Acronym / sponsor ID
- EK NR-348/98
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, coronary bypass surgery, complete arterial coronary surgery, internal mammary artery
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2,000 participants
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 1999
- Study completion
- Jan 2005
- First posted
- 24 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary bypass surgery | Procedure or surgery | – |
Primary outcome
All cause mortality perioperatively, one year, five and ten years.
1 secondary outcome
Combined cardiac death, non-fatal myocardial infarction and repeat revascularisation at one, five and ten years.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Simon, MD principal investigator
Dept. of Cardiothoracic Surgery, Medical Univ. of Vienna
14 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary bypass surgery in people with Coronary Artery Disease, run by Medical University of Vienna at 14 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Spain, Austria, Czechia, Norway and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality perioperatively, one year, five and ten years.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2006.