Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction

NACompletedINTERVENTIONAL
Enrollment

145

Participants

Timeline

Start Date

July 25, 2019

Primary Completion Date

August 31, 2022

Study Completion Date

February 6, 2023

Conditions
STEMIAnterior MI
Interventions
DEVICE

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.

Trial Locations (17)

31059

Centre Hospitalier Universitaire de Toulouse, Toulouse

Unknown

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

UB9 6JH

Royal Brompton and Harefield Hospital, Harefield

LS1 3EX

Leeds Teaching Hopsitals, Leeds

OX3 9DU

John Radcliffe Hospital, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Miracor Medical SA

INDUSTRY

NCT03625869 - Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction | Biotech Hunter | Biotech Hunter