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NCT Number: NCT04973579

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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).

Primary outcomes

  1. Freedom from major clinical complications comprising MACNE (major adverse cardiovascular or neurologic event) at 30 days

    Time frame: 30 days from index procedure

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

Secondary outcomes

  1. Freedom from major clinical complications comprising MACNE at 6 months

    Time frame: At 6 months from index procedure

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

  2. Freedom from major clinical complications comprising MACNE at 12 months

    Time frame: At 12 months from index procedure

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

  3. Procedural success rate for carotid stenting

    Time frame: Periprocedural

    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).

  4. Technical success

    Time frame: At the procedure completion

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

  5. Clinical success

    Time frame: Day 2 after procedure

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

  6. Rate of arterial access complications

    Time frame: Up to 24 hours post-procedure

    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.

  7. Rate of cardiac surgery related complications

    Time frame: Up to 24 hours post-procedure

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

  8. Rate of other major peri-procedural complications

    Time frame: Up to 7 days post-procedure

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

  9. Rate of ipsilateral stroke in the first year

    Time frame: From 31 days till 365 days post-procedure

    Occurence of any ipsilateral stroke

  10. Rate of ipsilateral stroke up to 5 years

    Time frame: From 1 year till 5 years post-procedure

    Occurence of any ipsilateral stroke

  11. Rate of any stroke up to 5 years

    Time frame: Untill 5 years post-procedure

    Occurence of any stroke during registry follow up

  12. Stroke free survival rate up to 1 year

    Time frame: Untill 1 year post-procedure

    Survival without any stroke up to 1 year follow up

  13. Ipsilateral stroke free survival rate up to 1 year

    Time frame: Untill 1 year post-procedure

    Survival without ipsilateral stroke up to 1 year follow up

  14. Stroke free survival rate up to 5 years

    Time frame: Untill 5 year post-procedure

    Survival without any stroke up to 5 year follow up

  15. Ipsilateral stroke free survival rate up to 5 years

    Time frame: Untill 5 year post-procedure

    Survival without ipsilateral stroke up to 5 year follow up

  16. Rate of coronary or carotid restenosis

    Time frame: Untill 5 year post-procedure

    Clinical coronary or carotid restenosis requiring treatment

  17. Rate of cardiac or carotid reintervention

    Time frame: Untill 5 year post-procedure

    Clinically indicated carotid or cardiac reintervention during folow up period

  18. Ultrasound Evaluated Carotid Artery Velocities

    Time frame: After procedure and at 12 months follow up

    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.

  19. Recurrence of angina or valvular heart disease at 30 days and 12 months

    Time frame: At 30 days and 12 months after surgery

    Recurrence of angina or symptomatic valvular heart disease

  20. Recurrence of angina or valvular heart disease up to 5 years

    Time frame: Up to 5 years thereafter after surgery

    Recurrence of angina or symptomatic valvular heart disease

  21. Feasibility of combined treatment

    Time frame: At the procedure completion

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

Study contacts

Contact information is provided by the study sponsor or research team.

Piotr Musialek, MD, DPhil

CONTACT

[email protected]

+48126142287

Sponsors and collaborators

Lead sponsor

John Paul II Hospital, Krakow

Other

Registry information

Official study 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

Acronym: SIM-GUARD

Important dates

Study start
2021
Primary completion
2022
Study completion
2027
First posted
Jul 22, 2021
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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