Simultaneous Cardiac Surgery and Micronet-covered Stent Carotid Revascularization in High Perioperative Stroke Risk Patients
Recruiting · NCT04973579 · Observational (researchers observe without assigning treatment) · Lead sponsor: John Paul II Hospital, Krakow
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Department of Cardiac and Vascular Diseases, John Paul II Hospital - Krakow, Poland