Skip to content

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04973579
Acronym
SIM-GUARD
Enrollment
50
Registered
2021-07-22
Start date
2021-05-01
Completion date
2027-05-01
Last updated
2021-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Carotid Stenosis, Coronary Artery Disease, Valvular Disease, Heart Failure, Pulmonary Edema, Single Anesthesia, Simultaneous Procedure

Brief 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.

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.

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).

Sponsors

John Paul II Hospital, Krakow
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Freedom from major clinical complications comprising MACNE (major adverse cardiovascular or neurologic event) at 30 days30 days from index procedureFreedom from any death, any stroke, and myocardial infarction at 30-day follow-up

Secondary

MeasureTime frameDescription
Freedom from major clinical complications comprising MACNE at 12 monthsAt 12 months from index procedureFreedom from any death, any stroke, and myocardial infarction at 12 months follow-up
Procedural success rate for carotid stentingPeriproceduralSuccess 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).
Technical successAt the procedure completionNumber of procedures (both carotid and coronary) completed in relation to the number of attempted procedures
Clinical successDay 2 after procedureNumber of procedures (both carotid and coronary) completed in relation to the number of attempted procedures in absence of stroke
Rate of arterial access complicationsUp to 24 hours post-procedurePeri-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.
Rate of cardiac surgery related complicationsUp to 24 hours post-procedurePeri-procedural complications associated with cardiac surgery - bleeding requiring re-thoracotomy, cardiac tamponade
Rate of other major peri-procedural complicationsUp to 7 days post-procedureOther major peri-procedural complications: acute renal failure, systemic infection, respiratory failure requiring prolonged ventilation (\>24 hours).
Rate of ipsilateral stroke in the first yearFrom 31 days till 365 days post-procedureOccurence of any ipsilateral stroke
Rate of ipsilateral stroke up to 5 yearsFrom 1 year till 5 years post-procedureOccurence of any ipsilateral stroke
Rate of any stroke up to 5 yearsUntill 5 years post-procedureOccurence of any stroke during registry follow up
Freedom from major clinical complications comprising MACNE at 6 monthsAt 6 months from index procedureFreedom from any death, any stroke, and myocardial infarction at 6 months follow-up
Ipsilateral stroke free survival rate up to 1 yearUntill 1 year post-procedureSurvival without ipsilateral stroke up to 1 year follow up
Stroke free survival rate up to 5 yearsUntill 5 year post-procedureSurvival without any stroke up to 5 year follow up
Ipsilateral stroke free survival rate up to 5 yearsUntill 5 year post-procedureSurvival without ipsilateral stroke up to 5 year follow up
Rate of coronary or carotid restenosisUntill 5 year post-procedureClinical coronary or carotid restenosis requiring treatment
Rate of cardiac or carotid reinterventionUntill 5 year post-procedureClinically indicated carotid or cardiac reintervention during folow up period
Ultrasound Evaluated Carotid Artery VelocitiesAfter procedure and at 12 months follow upPeak 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.
Recurrence of angina or valvular heart disease at 30 days and 12 monthsAt 30 days and 12 months after surgeryRecurrence of angina or symptomatic valvular heart disease
Recurrence of angina or valvular heart disease up to 5 yearsUp to 5 years thereafter after surgeryRecurrence of angina or symptomatic valvular heart disease
Feasibility of combined treatmentAt the procedure completionNumber of patients actually treated with combined treatment to the number of patients qualified for treatment (excluding deaths in-between)
Stroke free survival rate up to 1 yearUntill 1 year post-procedureSurvival without any stroke up to 1 year follow up

Countries

Poland

Contacts

Primary ContactPiotr Musialek, MD, DPhil
pmusialek@szpitaljp2.krakow.pl+48126142287

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026