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

RecruitingOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

May 1, 2021

Primary Completion Date

May 1, 2022

Study Completion Date

May 1, 2027

Conditions
Carotid StenosisCoronary Artery DiseaseValvular Heart DiseaseMyocardial InfarctionPulmonary Edema With Heart Failure
Interventions
PROCEDURE

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

"The registry enrolls patients qualified for treatment with the methods evaluated in the registry, using routinely applicable procedures and devices.~In cardiac surgery - surgical treatment systems for advanced ischemic heart disease and/or valvular disease (including - mechanical/biologic heart valves - regulatory approved for routine use and typically used at the Facility.~In the simultaneous treatment of stroke-threatening carotid artery atherosclerosis - temporary neuroprotection systems (proximal, distal, according to medical indications and local experience) - regulatory approved for routine use and typically used at the center (for over 20 years).~CGuard anti-embolic mesh stent system - a self-expanding nitinol carotid stent wrapped in MicroNet, which prevents fragments of atherosclerotic plaque from entering the lumen of the carotid artery - approved for routine use and typically used at the Center (over 5 years)."

Trial Locations (1)

31-202

RECRUITING

Department of Cardiac and Vascular Diseases, John Paul II Hospital, Krakow

All Listed Sponsors
lead

John Paul II Hospital, Krakow

OTHER