A Study to Evaluate Safety and Feasibility of PiCSO Therapy in Patients With ST Elevation Inferior Wall Myocardial Infarction.

NATerminatedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

February 14, 2022

Primary Completion Date

February 6, 2023

Study Completion Date

February 6, 2023

Conditions
STEMI - ST Elevation Myocardial InfarctionInferior Wall Myocardial Infarction
Interventions
DEVICE

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.

Trial Locations (11)

31059

Centre Hospitalier Universitaire de Toulouse, Toulouse

Unknown

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

OX3 9DU

John Radcliffe Hospital, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Miracor Medical SA

INDUSTRY

NCT04958421 - A Study to Evaluate Safety and Feasibility of PiCSO Therapy in Patients With ST Elevation Inferior Wall Myocardial Infarction. | Biotech Hunter | Biotech Hunter