Simultaneous carotid artery stenting and cardiac surgery for high-risk patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.