RecruitingNCT04973579

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

SIMultaneous Urgent Cardiac Surgery and Endovascular Stroke Prevention Using the Micronet-covered CGUARD Stent in Hemodynamically Compromised Patients at Increased Peri-operative Stroke Risk: SIM-GUARD Study

Sponsor

John Paul II Hospital, Krakow

Enrollment

50 participants

Start Date

May 1, 2021

Study Type

OBSERVATIONAL

Conditions

Myocardial Infarction Coronary Artery Disease Valvular Heart Disease Carotid Stenosis Pulmonary Edema With Heart Failure

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

Min Age: 18 Years

Inclusion Criteria8

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 Criteria13

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.

Interventions

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

The 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).