Prospective, single-center, clinical registry of patients with symptomatic/critical carotid artery stenosis at risk of stroke coexisting with unstable or multivessel severe coronary artery disease and/or severe valvular heart disease undergoing endovascular treatment of carotid atherosclerosis using a mesh stent in combination with cardiac surgery (coronary artery bypass grafting (CABG) and/or valve surgery). A study involving clinical data evaluation of truly simultaneous treatment outcomes in patients deemed to require carotid revascularization at the time of surgical cardiac intervention (single-stage, simultaneous treatment). An open-label study, without randomization - a single arm study.
Academic Registry - scientific activity of the Faculty of Medicine, Collegium Medicum, Jagiellonian University and John Paul II Hospital.
Patients eligible for concomitant carotid artery stenting in conjunction with cardiac surgery based on Heart Team and NeuroVascular Team reccomendation and according to local standards of practice.
Signed informed consent form
Consent to (routinely performed in this group of patients) follow-up visits and tests performed (routinely) during long-term follow-up
De novo atherosclerotic lesions or neo-atherosclerosis.
Expected survival time <1 year (e.g., cancer).
Renal failure with GFR < 20 ml/min/1.73 m2 as calculated by the CKD-EPI formula
Women who are pregnant (pregnancy test).
Coagulopathies.
All-comers registry of patients with Heart and NeuroVascular Team recommendation for single-stage simultaneous surgical and endovascular procedure. The SIM-GUARD single arm registry design and exploratory nature precluded sample size calculation. The number of patients to be enrolled is selected based on the number of procedures at the Center and the average typical size of studies/registries in this field of interventional treatment.
Cohort
Prospective
Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement / repair procedure)
Procedure/SurgeryThe registry enrolls patients qualified for treatment with the methods evaluated in the registry, using routinely applicable procedures and devices. In cardiac surgery - surgical treatment systems for advanced ischemic heart disease and/or valvular disease (including - mechanical/biologic heart valves - regulatory approved for routine use and typically used at the Facility. In the simultaneous treatment of stroke-threatening carotid artery atherosclerosis - temporary neuroprotection systems (proximal, distal, according to medical indications and local experience) - regulatory approved for routine use and typically used at the center (for over 20 years). CGuard anti-embolic mesh stent system - a self-expanding nitinol carotid stent wrapped in MicroNet, which prevents fragments of atherosclerotic plaque from entering the lumen of the carotid artery - approved for routine use and typically used at the Center (over 5 years).
Freedom from major clinical complications comprising MACNE (major adverse cardiovascular or neurologic event) at 30 days
Freedom from any death, any stroke, and myocardial infarction at 30-day follow-up
Freedom from major clinical complications comprising MACNE at 6 months
Freedom from any death, any stroke, and myocardial infarction at 6 months follow-up
Freedom from major clinical complications comprising MACNE at 12 months
Freedom from any death, any stroke, and myocardial infarction at 12 months follow-up
Procedural success rate for carotid stenting
Success of endovascular treatment of carotid artery stenosis i.e. technical success (stent delivery and implantation, withdrawal of stent delivery system, residual stenosis ≤30% of vessel lumen diameter) plus clinical success (procedure without complications).
Technical success
Number of procedures (both carotid and coronary) completed in relation to the number of attempted procedures
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