200
Participants
Start Date
January 1, 2019
Primary Completion Date
September 30, 2022
Study Completion Date
June 30, 2023
Selective intracoronary hypothermia + PPCI
Selective intracoronary hypothermia is a new technique, recently tested for safety and feasibility in the SINTAMI trial. The procedure starts by advancing a guidewire beyond the occlusion in the culprit artery, followed by an OTWB that is inflated at the location of the occlusion, at a low pressure (4 atm), to prevent reperfusion. After that, a pressure/temperature wire will be advanced along the inflated OTWB and is placed in the distal coronary artery. Then the guidewire is removed and the lumen is used for infusion of saline. During the 'occlusion phase', saline at room temperature is infused for 10 minutes with distal coronary temperature 6-8°C below body temperature. After that, the balloon of the OTWB is deflated. Simultaneously, infusion is started with saline of 4°C, the so called 'reperfusion phase'. This is continued for 10 more minutes. After that, the OTWB can be retracted and the procedure can continue not different from routine PPCI.
Standard PPCI
PPCI per routine
Catharina hospital, Eindhoven
Collaborators (1)
Abbott
INDUSTRY
Golden Jubilee National Hospital
OTHER_GOV
Onze Lieve Vrouwziekenhuis Aalst
OTHER
Rigshospitalet, Denmark
OTHER
Örebro University, Sweden
OTHER
Skane University Hospital
OTHER
University of Belgrade
OTHER
Mid and South Essex NHS Foundation Trust
OTHER
Catharina Ziekenhuis Eindhoven
OTHER