Simultaneous Cardiac Surgery and Micronet-covered Stent Carotid Revascularization in High
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 com
| Condition(s) | Carotid Stenosis, Coronary Artery Disease, Valvular Heart Disease, Myocardial Infarction, Pulmonary Edema With Heart Failure |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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, Jagielloni |
| Who can participate | 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 multivesse |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | John Paul II Hospital, Krakow |
| Locations | Krakow, Poland |
| Start date | 2021-05-01 |
| NCT ID | NCT04973579 |
| Official listing | https://clinicaltrials.gov/study/NCT04973579 |