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.

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

Carotid Stenosis

Coronary Artery Disease

Valvular Heart Disease

Myocardial Infarction

Pulmonary Edema With Heart Failure

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.

Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement / repair procedure)

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

Freedom from any death, any stroke, and myocardial infarction at 30-day follow-up

Freedom from any death, any stroke, and myocardial infarction at 6 months follow-up

Freedom from any death, any stroke, and myocardial infarction at 12 months follow-up

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).

Number of procedures (both carotid and coronary) completed in relation to the number of attempted procedures

Number of procedures (both carotid and coronary) completed in relation to the number of attempted procedures in absence of stroke

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.

Peri-procedural complications associated with cardiac surgery - bleeding requiring re-thoracotomy, cardiac tamponade

Other major peri-procedural complications: acute renal failure, systemic infection, respiratory failure requiring prolonged ventilation (>24 hours).

Occurence of any stroke during registry follow up

Survival without any stroke up to 1 year follow up

Survival without ipsilateral stroke up to 1 year follow up

Survival without any stroke up to 5 year follow up

Survival without ipsilateral stroke up to 5 year follow up

Clinical coronary or carotid restenosis requiring treatment

Clinically indicated carotid or cardiac reintervention during folow up period

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.

Recurrence of angina or symptomatic valvular heart disease

Number of patients actually treated with combined treatment to the number of patients qualified for treatment (excluding deaths in-between)

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)

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

About this trial

Study ID

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Type

Placebo

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What is this trial about?

What are the participation requirements?

Locations

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