25
Participants
Start Date
February 14, 2022
Primary Completion Date
February 6, 2023
Study Completion Date
February 6, 2023
PiCSO Impulse System
After blood flow restoration, the subjects meeting all eligibility criteria will be enrolled into the study and randomized either to PiCSO Group or Control Group. If the subject is randomized to PiCSO Group, the coronary sinus (CS) will be cannulated through the femoral vein and the PiCSO Impulse Catheter will be placed in the CS. Once PiCSO Impulse Catheter is placed into CS, PiCSO treatment is started followed by stenting. The physician shall target a PiCSO treatment of 45 minutes whereas the treatment should be continued during and post stent insertion. At the end of the PiCSO treatment, the PiCSO Impulse Console is stopped and the PiCSO Impulse Catheter is removed.
Centre Hospitalier Universitaire de Toulouse, Toulouse
Aarhus Universitetshospital, Aarhus
Odense Universitetshospital, Odense
CHU Hôpiteaux de Bordeaux, Hôpital Haut Lévéque, Bordeaux
Centre Hospitalier Régional Universitaire de Lille, Lille
Pauls Stradins Clinical University Hospital, Riga
Bern University Hospital, Bern
EOC Ospedale Regionale di Lugano - Civico, Lugano
Golden Jubilee National Hospital, Clydebank
New Edinburgh Royal Infirmary, Edinburgh
John Radcliffe Hospital, Oxford
Lead Sponsor
Miracor Medical SA
INDUSTRY