Coronary heart disease, carotid artery stenosis Circulatory System Coronary heart disease
Conditions
Interventions
CABG with or without CEA must be performed as soon as possible (max. within 7 days) after randomisation. All patients will be treated with up-to-date medication following national and international gu
Sponsors
University Hospital Essen (Universitatsklinikum Essen) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following criteria will be considered for admission to the trial: 1. Asymptomatic (past 180 days) stenosis greater than or equal to 80% (following criteria of the ECST of the extracranial carotid artery in patients scheduled for CABG) 2. Negative pregnancy test in pre-menopausal women 3. Written informed consent and full legal capacity 4. Carotid stenosis treatable with CEA 5. Ability of the patient to participate in follow-up examinations 6. Aged greater than or equal to 18 years, either sex
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 09/04/2013: Subjects presenting with any of the following criteria will not be included in the trial: 1. Non-atherosclerotic stenosis (e.g. dissection, floating thrombus, fibromuscular dysplasia, tumor) 2. Complete occlusion of the carotid artery to be treated 3. Prior stenting of the carotid artery to be treated 4. Stenosis following radiotherapy 5. Additional higher grade intracranial or intrathoracic stenosis (tandem stenosis) 6. Recent (past 180 days) ischemic symptoms ipsilateral to carotid stenosis or occlusion 7. Contralateral carotid occlusion or other known indication for carotid revascularization (apart from scheduled CABG) 8. NSTEMI within the past 48 hours, STEMI within the past 7 days or hemodynamically unstable patients 9. Evidence for intracranial bleeding within the past 90 days 10. Modified Rankin Scale score >3 or severe aphasia 11. Patients unlikely to survive more than 1 year due to concomitant diseases 12. Planned combined cardiac valve replacement or any other cardiac surgery beyond CABG (+/- CEA) during the procedure 13. Major surgery (apart from study procedures) planned within 8 weeks from randomization 14. Participation in another clinical trial Previous exclusion criteria until 09/04/2013: Subjects presenting with any of the following criteria will not be included in the trial: 1. Non-atherosclerotic stenosis (e.g. dissection, floating thrombus, fibromuscular dysplasia, tumor) 2. Complete occlusion of the carotid artery to be treated 3. Prior stenting of the carotid artery to be treated 4. Stenosis following radiotherapy 5. Additional higher grade intracranial or intrathoracic stenosis (tandem stenosis) 6. Recent (past 180 days) ischemic symptoms ipsilateral to carotid stenosis or occlusion 7. Contralateral carotid occlusion or other known indication for carotid revascularization (apart from scheduled CABG) 8. Myocardial infarction (NSTEMI or STEMI) within the past 7 days or hemodynamically unstable patients 9. Known high risk for cardiogenic embolism requiring anticoagulation (mechanical heart valve, chronic atrial fibrillation, left ventricular thrombus, left ventricular aneurysm) 10. Evidence for intracranial bleeding within the past 90 days 11. Modified Rankin Scale score >3 or severe aphasia 12. Patients unlikely to survive more than 1 year due to concomitant diseases 13. Planned combined cardiac valve replacement or any other cardiac surgery beyond CABG (+/- CEA) during the procedure 14. Major surgery (apart from study procedures) planned within 8 weeks from randomization 15. Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy and safety endpoint is the event rate of nonfatal strokes or deaths from any cause (whatever occurs first) within 30 days after the intervention (either isolated CABG or synchronous CABG + CEA). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of ischemic strokes ipsilateral to the initially higher grade, not occluded stenotic carotid artery within 30 days and 1 year 2. Any stroke or vascular death within 30 days, 1 year and 5 years 3. Deaths from any cause within 30 days, 1 year and 5 years 4. Number of disabling strokes (definition: stroke with resulting impairment >3 on the modified Rankin Scale) within 30 days and 1 year 5. Change of cognitive performance on the Demtec scale from randomization to 30 days and 1 year 6. Technical failure of intervention 7. Number of myocardial infarctions within 30 days, and from 30 days to 1 year 8. Duration of ventilatory support after operation (CABG ± CEA) 9. Total length of hospital stay and German diagnosis related group (G-DRG) for acute hospital stay 10. Total length of ICU stay | — |
Countries
Germany
Outcome results
None listed