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Carotid stent and heart surgery done together in high-risk patients

Studies a neck artery stent during heart surgery in adults with narrowed carotid arteries.

Key facts

Who runs it
John Paul II Hospital, Krakow
Where
Krakow, PolandSee the site
Trial code
Registry title
Simultaneous Cardiac Surgery and Micronet-covered Stent Carotid Revascularization in High Perioperative Stroke Risk Patients
Status
Recruiting
People taking part
50 people, planned
Started
1 May 2021
Expected to end
1 May 2027
Type of study
Observational
Treatments tested
  • Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement / repair procedure)
Record updated
22 July 2021

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with narrowed neck arteries (carotid stenosis) who also need heart surgery. Both are treated in one operation: a mesh stent in the carotid artery plus bypass and/or valve surgery.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Narrowing of the carotid artery of 50% or more with symptoms in the past 6 months, or 70-80% or more with no symptoms. Also unstable or multivessel severe coronary disease and/or severe symptomatic valve disease needing heart surgery.

Main reasons for not taking part

  • Expected survival under 1 year (for example cancer)
  • Severe kidney failure (GFR under 20 ml/min/1.73 m2)
  • Pregnancy
  • Carotid artery completely blocked
  • Blood clotting disorders

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Expected survival time <1 year (e.g., cancer)
  • History of hypersensitivity to a contrast agent that does not respond to pharmacotherapy
  • Renal failure with GFR < 20 ml/min/1.73 m2 as calculated by the CKD-EPI formula
  • Women who are pregnant (pregnancy test)
  • Coagulopathies
  • 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

Where in Poland

  • Department of Cardiac and Vascular Diseases, John Paul II HospitalKrakow, PolandContact: Piotr Musialek, MD, DPhilTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

Academic Registry - scientific activity of the Faculty of Medicine, Collegium Medicum, Jagiellonian University and John Paul II Hospital.

The group in the trial

  • Simultaneous cardiac surgery and carotid stenting

    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)

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Carotid stent and heart surgery done together in high-risk patientsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
22 July 2021