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

Coronary Artery Disease Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The coexistence of symptomatic or unstable stroke-threatening carotid atherosclerotic stenosis with cardiac disease requiring urgent / fast-track cardiac surgery (such as advanced unstable or multivessel coronary artery disease, recent myocardial infarction or pulmonary edema, severely impaired myocardial contractility, and/or severe valvular disease requiring surgical treatment) represents a major medical and therapeutic/logistics challenge.

According to current guidelines, in absence of prospective randomized evidence, the most appropriate management strategy for a given patient should be determined by a multispecialty team. In hemodynamically compromised patients sequential treatment (i.e., first carotid stenosis repair followed by surgery or first cardiac surgery followed by carotid stenosis treatment, either surgical or endovascular) is associated with a high risk of cardiac complications in case of first-stage carotid stenosis treatment and a high risk of neurological complications in case of the first-stage cardiac surgery.

In this challenging patient group, we have introduced single-stage, truly simultaneous procedure. The fundament of the strategy is to establish extracorporeal circulation back-up ("CEC standby") prior to the minimally invasive (endovascular) treatment of stroke-threatening carotid artery stenosis in the hybrid room under single anesthesia.

For CAS (proximal or distal protected), in case of suboptimal femoral access (or lack of femoral access), a direct access via carotid artery is used (transcervical or transcarotid revascularization), this is immediately followed by cardiac surgery.

The procedure, each time, follows recommendation of the Multispecialty Team (Heart Team + NeuroVascular Team) as the lowest-deemed risk management in patients with indications for both urgent both carotid revascularization and cardiac surgery. Both carotid and cardiac treatment are performed under single anesthesia with the feasibility of immediate extracorporeal circulation support during carotid revascularization in case of hemodynamic collapse.

Eligibility for treatment is based on the decision (recommendation) of a multidisciplinary Heart Team along with a NeuroVascular Team consisting of a cardiac surgeon, cardiologist, anesthesiologist, angiologist, neurologist, and vascular surgeon, with the concomitant use of routine pharmacotherapy and non-pharmacological prevention - according to current guidelines. ;

Related Conditions & MeSH terms

• Carotid Stenosis
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Heart Failure
• Heart Valve Diseases
• Myocardial Infarction
• Myocardial Ischemia
• Pulmonary Edema
• Pulmonary Edema With Heart Failure
• Valvular Heart Disease

• NCT number: NCT04973579
• Study type: Observational
• Source: John Paul II Hospital, Krakow
• Contact: Piotr Musialek, MD, DPhil
• Phone: +48126142287
• Email: pmusialek@szpitaljp2.krakow.pl
• Status: Recruiting
• Start date: May 1, 2021
• Completion date: May 1, 2027