Simultaneous Cardiac Surgery and Micronet-covered Stent Carotid Revascularization in High Perioperative Stroke Risk Patients

Summary

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.

Eligibility

Inclusion Criteria:

* 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.
* Symptomatic patients (with a history of ipsilateral transient cerebral ischemia, stroke or amaurosis fugax within the past 6 months) with carotid artery stenosis ≥50% as assessed by NASCET angiography or
* Asymptomatic patients with carotid artery stenosis ≥70-80% as assessed by angiography (NASCET method).
* Coronary angiography-confirmed multivessel disease or left main stem stenosis with the symptoms of unstable angina or non-ST-segment elevation myocardial infarction.
* Severe symptomatic valvular disease detected by echocardiography.

Exclusion Criteria:

* 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.
* History of hypersensitivity to a contrast agent that does not respond to pharmacotherapy.
* Total carotid artery occlusion.
* Stent in the carotid artery that protrudes into the aortic arch.
* Anatomic variants that preclude stent implantation.
* Significant stenosis of the common carotid artery proximal to the target lesion.
* Mobile atherosclerotic plaques in the aortic arch.
* Anatomy of the coronary arteries unsuitable for bypass grafting.
* Lack of available vascular material for grafting.
* Porcelain aorta.

Conditions6

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