A Study to Evaluate the Safety and Efficacy of PiCSO in Anterior STEMI Patients

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

March 30, 2023

Primary Completion Date

July 31, 2025

Study Completion Date

June 30, 2028

Conditions
STEMI - ST Elevation Myocardial InfarctionAnterior 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.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Miracor Medical SA

INDUSTRY

NCT05497011 - A Study to Evaluate the Safety and Efficacy of PiCSO in Anterior STEMI Patients | Biotech Hunter | Biotech Hunter