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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Coronary Artery Disease; Carotid Stenosis; Valvular Heart Disease; Pulmonary Edema With Heart Failure
• Intervention / Treatment: Procedure: Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement / repair procedure)

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Piotr Musialek, MD, DPhil; Phone Number: +48126142287; Email: pmusialek@szpitaljp2.krakow.pl

Study Locations

• Poland
  • Krakow, Poland, 31-202
    • Recruiting
    • Department of Cardiac and Vascular Diseases, John Paul II Hospital
    • Contact: Piotr Musialek, MD, DPhil; Phone Number: +48126142287; Email: pmusialek@szpitaljp2.krakow.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All-comers registry of patients with Heart and NeuroVascular Team recommendation for single-stage simultaneous surgical and endovascular procedure.

The SIM-GUARD single arm registry design and exploratory nature precluded sample size calculation. The number of patients to be enrolled is selected based on the number of procedures at the Center and the average typical size of studies/registries in this field of interventional treatment.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Simultaneous cardiac surgery and carotid stenting; Patients with Heart Team and NeuroVascular Team recommendation to perform simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) including proximal or distal neuroembolic protection and cardiac surgery (CABG or surgical valve replacement / repair procedure)

Procedure: Simutaneous (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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from major clinical complications comprising MACNE (major adverse cardiovascular or neurologic event) at 30 days	Freedom from any death, any stroke, and myocardial infarction at 30-day follow-up	30 days from index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from major clinical complications comprising MACNE at 6 months	Freedom from any death, any stroke, and myocardial infarction at 6 months follow-up	At 6 months from index procedure
Freedom from major clinical complications comprising MACNE at 12 months	Freedom from any death, any stroke, and myocardial infarction at 12 months follow-up	At 12 months from index procedure
Procedural success rate for carotid stenting	Success of endovascular treatment of carotid artery stenosis i.e. technical success (stent delivery and implantation, withdrawal of stent delivery system, residual stenosis ≤30% of vessel lumen diameter) plus clinical success (procedure without complications).	Periprocedural
Technical success	Number of procedures (both carotid and coronary) completed in relation to the number of attempted procedures	At the procedure completion
Clinical success	Number of procedures (both carotid and coronary) completed in relation to the number of attempted procedures in absence of stroke	Day 2 after procedure
Rate of arterial access complications	Peri-procedural vascular access complications of carotid artery stenting (pseudoaneurysm of the femoral artery, acute ischemia of the lower limb, massive bleeding from the puncture site) occurring within 24 hours.	Up to 24 hours post-procedure
Rate of cardiac surgery related complications	Peri-procedural complications associated with cardiac surgery - bleeding requiring re-thoracotomy, cardiac tamponade	Up to 24 hours post-procedure
Rate of other major peri-procedural complications	Other major peri-procedural complications: acute renal failure, systemic infection, respiratory failure requiring prolonged ventilation (>24 hours).	Up to 7 days post-procedure
Rate of ipsilateral stroke in the first year	Occurence of any ipsilateral stroke	From 31 days till 365 days post-procedure
Rate of ipsilateral stroke up to 5 years	Occurence of any ipsilateral stroke	From 1 year till 5 years post-procedure
Rate of any stroke up to 5 years	Occurence of any stroke during registry follow up	Untill 5 years post-procedure
Stroke free survival rate up to 1 year	Survival without any stroke up to 1 year follow up	Untill 1 year post-procedure
Ipsilateral stroke free survival rate up to 1 year	Survival without ipsilateral stroke up to 1 year follow up	Untill 1 year post-procedure
Stroke free survival rate up to 5 years	Survival without any stroke up to 5 year follow up	Untill 5 year post-procedure
Ipsilateral stroke free survival rate up to 5 years	Survival without ipsilateral stroke up to 5 year follow up	Untill 5 year post-procedure
Rate of coronary or carotid restenosis	Clinical coronary or carotid restenosis requiring treatment	Untill 5 year post-procedure
Rate of cardiac or carotid reintervention	Clinically indicated carotid or cardiac reintervention during folow up period	Untill 5 year post-procedure
Ultrasound Evaluated Carotid Artery Velocities	Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the internal carotid/common carotid artery assessed by ultrasound - after the procedure, then at 12 months after the procedure.	After procedure and at 12 months follow up
Recurrence of angina or valvular heart disease at 30 days and 12 months	Recurrence of angina or symptomatic valvular heart disease	At 30 days and 12 months after surgery
Recurrence of angina or valvular heart disease up to 5 years	Recurrence of angina or symptomatic valvular heart disease	Up to 5 years thereafter after surgery
Feasibility of combined treatment	Number of patients actually treated with combined treatment to the number of patients qualified for treatment (excluding deaths in-between)	At the procedure completion

Collaborators and Investigators

• Sponsor: John Paul II Hospital, Krakow
• Investigators: Principal Investigator: Piotr Musialek, MD, DPhil, Department of Cardiac and Vascular Diseases, John Paul II Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2027

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Carotid Stenosis; Coronary Artery Disease, Valvular Disease; Heart Failure, Pulmonary Edema; Single Anesthesia; Simultaneous Procedure
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Lung Diseases; Carotid Artery Diseases; Infarction; Myocardial Infarction; Heart Failure; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Carotid Stenosis; Heart Valve Diseases; Pulmonary Edema; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: SIM-GUARD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No