145
Participants
Start Date
July 25, 2019
Primary Completion Date
August 31, 2022
Study Completion Date
February 6, 2023
PiCSO
After blood flow restoration, the subjects meeting all inclusion and none exclusion criterial 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 (at minimum 30 minutes) whereas the treatment should be continued during and post stent insertion, but should not exceed a maximum duration of 90 minutes. 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 University Hospital, Odense
CHU Hôpiteaux de Bordeaux, Hôpital Haut Lévéque, Bordeaux
Centre Hospitalier Régional Universitaire de Lille, Lille
Klinikum Coburg GmbH, Coburg
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
Liverpool Heart and Chest Hospital, Liverpool
St Bartholomew's Hospital, London
Freeman Hospital, Newcastle
Royal Brompton and Harefield Hospital, Harefield
Leeds Teaching Hopsitals, Leeds
John Radcliffe Hospital, Oxford
Lead Sponsor
Miracor Medical SA
INDUSTRY