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

Launched by JOHN PAUL II HOSPITAL, KRAKOW · Jul 13, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new approach for patients who have severe narrowing of the carotid artery (carotid stenosis) and also have serious heart conditions, such as blocked coronary arteries or heart valve disease. The goal is to see how well patients do when they receive treatment for both issues at the same time—using a special type of stent to open up the carotid artery while also undergoing heart surgery, like bypass surgery or valve repair. This study is particularly focused on those who are at high risk for stroke during surgery.

To participate in this trial, candidates generally need to be between 65 and 74 years old and have symptoms like a recent stroke or severe chest pain related to their heart problems. They should also be able to give their consent for the study and agree to follow-up visits after the procedure. Participants can expect to be part of a closely monitored process where their health outcomes will be evaluated over time to see how well this combined treatment works. It’s important to note that certain individuals, like those with severe kidney problems or pregnant women, won't be eligible for this trial.

Gender

ALL

Eligibility 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.