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

Plain Language Summary

Simplified for easier understanding

This study is evaluating a combined surgical approach: performing heart surgery and a carotid artery procedure (using a special stent to open a blocked neck artery) at the same time, to reduce the risk of stroke during heart surgery in high-risk patients. **You may be eligible if...** - You need heart surgery and have also been assessed as needing carotid artery treatment at the same time by a heart and neurovascular team - You have symptoms related to your carotid blockage (such as a recent mini-stroke, full stroke, or sudden temporary vision loss) with 50% or more carotid narrowing, OR - You have no symptoms but have 70–80% or more carotid narrowing on imaging - You have coronary artery disease confirmed by angiography affecting multiple vessels - You consent to the procedure and to long-term follow-up **You may NOT be eligible if...** - You do not have significant carotid disease meeting the threshold - You are not considered a candidate for combined surgery by the treating team - You are unable or unwilling to consent and attend follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).