Clinical trial NCT04973579: Simultaneous Cardiac Surgery and Micronet-covered Stent Carotid Revascularization in High Perioperative Stroke Risk Patients
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carotid Stenosis
Coronary Artery Disease
Valvular Heart Disease
Myocardial Infarction
Pulmonary Edema With Heart Failure
Keywords: Carotid Stenosis
Coronary Artery Disease, Valvular Disease
Heart Failure, Pulmonary Edema
Single Anesthesia
Simultaneous Procedure
Lead sponsor: John Paul II Hospital, Krakow
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from major clinical complications comprising MACNE (major adverse cardiovascular or neurologic event) at 30 days
timeFrame: 30 days from index procedure
Secondary outcomes:
measure: Freedom from major clinical complications comprising MACNE at 6 months
timeFrame: At 6 months from index procedure
measure: Freedom from major clinical complications comprising MACNE at 12 months
timeFrame: At 12 months from index procedure
measure: Procedural success rate for carotid stenting
timeFrame: Periprocedural
measure: Technical success
timeFrame: At the procedure completion
measure: Clinical success
timeFrame: Day 2 after procedure
measure: Rate of arterial access complications
timeFrame: Up to 24 hours post-procedure
measure: Rate of cardiac surgery related complications
timeFrame: Up to 24 hours post-procedure
measure: Rate of other major peri-procedural complications
timeFrame: Up to 7 days post-procedure
measure: Rate of ipsilateral stroke in the first year
timeFrame: From 31 days till 365 days post-procedure
measure: Rate of ipsilateral stroke up to 5 years
timeFrame: From 1 year till 5 years post-procedure
measure: Rate of any stroke up to 5 years
timeFrame: Untill 5 years post-procedure
measure: Stroke free survival rate up to 1 year
timeFrame: Untill 1 year post-procedure
measure: Ipsilateral stroke free survival rate up to 1 year
timeFrame: Untill 1 year post-procedure
measure: Stroke free survival rate up to 5 years
timeFrame: Untill 5 year post-procedure
measure: Ipsilateral stroke free survival rate up to 5 years
timeFrame: Untill 5 year post-procedure
measure: Rate of coronary or carotid restenosis
timeFrame: Untill 5 year post-procedure
measure: Rate of cardiac or carotid reintervention
timeFrame: Untill 5 year post-procedure
measure: Ultrasound Evaluated Carotid Artery Velocities
timeFrame: After procedure and at 12 months follow up
measure: Recurrence of angina or valvular heart disease at 30 days and 12 months
timeFrame: At 30 days and 12 months after surgery
measure: Recurrence of angina or valvular heart disease up to 5 years
timeFrame: Up to 5 years thereafter after surgery
measure: Feasibility of combined treatment
timeFrame: At the procedure completion
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Department of Cardiac and Vascular Diseases, John Paul II Hospital
Study officials:
affiliation: Department of Cardiac and Vascular Diseases, John Paul II Hospital
name: Piotr Musialek, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
References: