Simultaneous carotid artery stenting and cardiac surgery for high-risk patients
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
This study tests if doing carotid artery stenting at the same time as heart surgery can help high-risk patients with both conditions recover better and have fewer complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | John Paul II Hospital, Krakow Academic / other |
| Locations | 1 site (Krakow) |
| Trial ID | NCT04973579 on ClinicalTrials.gov |
What this trial studies
This clinical registry focuses on patients with symptomatic carotid artery stenosis who also have severe coronary artery disease or valvular heart disease requiring urgent surgery. It evaluates the outcomes of performing carotid revascularization using a mesh stent simultaneously with cardiac surgery under a single anesthesia. The study aims to address the high risks associated with sequential treatments by implementing a single-stage procedure that combines both interventions. Patients will be monitored for long-term outcomes following this innovative approach.
Who should consider this trial
Good fit: Ideal candidates include patients with symptomatic carotid stenosis and unstable coronary artery disease or severe valvular heart disease requiring urgent surgical intervention.
Not a fit: Patients who are asymptomatic with carotid stenosis less than 50% or those without significant cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of stroke and cardiac complications in high-risk patients undergoing simultaneous procedures.
How similar studies have performed: While similar approaches have been explored, this specific simultaneous treatment strategy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Krakow
- Department of Cardiac and Vascular Diseases, John Paul II Hospital — Krakow, Poland (Recruiting)
Study contacts
- Principal investigator: Piotr Musialek, MD, DPhil — Department of Cardiac and Vascular Diseases, John Paul II Hospital
- Study coordinator: Piotr Musialek, MD, DPhil
- Email: pmusialek@szpitaljp2.krakow.pl
- Phone: +48126142287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.