NCT04973579Recruiting
Simultaneous Cardiac Surgery and Micronet-covered Stent Carotid Revascularization in High Perioperative Stroke 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
Source: ClinicalTrials.gov · Last updated 22 Jul 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 13 Jul 2021
- Start date
- 1 May 2021
- Primary completion date
- 1 May 2022
- Lead sponsor
- John Paul II Hospital, Krakow
- Diseases
- Heart failure, Coronary artery disease, Stroke
- NCT number
- NCT04973579
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 May 2021 to the primary completion date, 1 May 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Expected survival time \<1 year (e.g., cancer).
- History of hypersensitivity to a contrast agent that does not respond to pharmacotherapy.
Lab values
- Renal failure with GFR \< 20 ml/min/1.73 m2 as calculated by the CKD-EPI formula
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Cardiac and Vascular Diseases, John Paul II Hospital Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.