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

Recruitingn/aAges 18 Years - anyAllJohn Paul II Hospital, Krakow
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ50% as assessed by NASCET angiography or * Asymptomatic patients with carotid artery stenosis โ‰ฅ70-80% 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.
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What it tests

  • Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement / repair procedure)
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Where

1 site
Department of Cardiac and Vascular Diseases, John Paul II Hospital
Krakow, Poland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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