An observational study in Carotid Stenosis, Coronary Artery Disease and Valvular Heart Disease, sponsored by John Paul II Hospital, Krakow. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-22.
Sponsored by John Paul II Hospital, Krakow · Observational
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.
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.
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.
Exclusion Criteria:
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).
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
Time frame: 30 days from index procedure
Freedom from major clinical complications comprising MACNE at 6 months
Freedom from any death, any stroke, and myocardial infarction at 6 months follow-up
Time frame: 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
Time frame: 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).
Time frame: Periprocedural
Technical success
Number of procedures (both carotid and coronary) completed in relation to the number of attempted procedures
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: Up to 7 days post-procedure
Rate of ipsilateral stroke in the first year
Occurence of any ipsilateral stroke
Time frame: From 31 days till 365 days post-procedure
Rate of ipsilateral stroke up to 5 years
Occurence of any ipsilateral stroke
Time frame: From 1 year till 5 years post-procedure
Rate of any stroke up to 5 years
Occurence of any stroke during registry follow up
Time frame: Untill 5 years post-procedure
Stroke free survival rate up to 1 year
Survival without any stroke up to 1 year follow up
Time frame: Untill 1 year post-procedure
Ipsilateral stroke free survival rate up to 1 year
Survival without ipsilateral stroke up to 1 year follow up
Time frame: Untill 1 year post-procedure
Stroke free survival rate up to 5 years
Survival without any stroke up to 5 year follow up
Time frame: Untill 5 year post-procedure
Ipsilateral stroke free survival rate up to 5 years
Survival without ipsilateral stroke up to 5 year follow up
Time frame: Untill 5 year post-procedure
Rate of coronary or carotid restenosis
Clinical coronary or carotid restenosis requiring treatment
Time frame: Untill 5 year post-procedure
Rate of cardiac or carotid reintervention
Clinically indicated carotid or cardiac reintervention during folow up period
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: At the procedure completion
Plan to share: Undecided
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John Paul II Hospital, Krakow