I25 I65.2
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Key inclusion criteria: 1. Identification of a =80% stenosis (ECST criteria) of the extracranial carotid artery in a patient scheduled for coronary artery bypass graft (CABG) surgery with the stenosis being asymptomatic for the past 180 days 2. Carotid stenosis treatable with CEA 3. Written informed consent 4. Male or female patients of age =18 years
Exclusion criteria
Exclusion criteria: Key exclusion criteria: 1. Stenosis related neurological symptoms within the previous 180 days 2. Non-atherosclerotic origin of stenosis 3. NSTEMI within the past 48 hours, STEMI within the past 7 days or hemodynamically unstable patients 4. Modified Rankin Scale score >3 or severe aphasia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy 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 |
|---|---|
| Secondary efficacy endpoints are single components of the primary endpoint, myocardial infarction, technical failures, duration of ventilatory support, change of cognitive performance on the Demtec scale and observations at different time points. | — |
Countries
Czechia, Germany
Contacts
Klinik für Thorax und kardiovaskuläre Chirurgie Universitätsklinikum Essen