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Observational Registry to Evaluate Real World Usage of PiCSO Impulse System in STEMI Patients as Part of Post-marketing Surveillance — PiCSO-AMI-IV  

STEMI - ST Elevation Myocardial Infarction Clinical Trial

Official title:
Observational Registry to Evaluate Real World Usage of PiCSO Impulse System in STEMI Patients as Part of Post-marketing Surveillance

Clinical Trial Summary

A prospective, multicenter, single-arm, open label registry of commercially treated patients with PiCSO Impulse System.

Clinical Trial Description

This is a observational registry study. Patients with an ST-segment elevated anterior infarct eligible for PCI and commercial PiCSO treatment will be invited to participate in the PiCSO-AMI-IV study. After having given consent as per approved ethics committee requirements, the PCI of the culprit vessel should be performed per standard practices. After blood flow restoration, the coronary sinus (CS) will be cannulated through the femoral vein and the PiCSO Impulse Catheter will be placed in the CS to start the PiCSO therapy. After the procedure the patient will be followed for safety assessments at 30 days, 6 months, 1 year, 2 year and 3 years post index procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04566289
Study type Observational [Patient Registry]
Source Miracor Medical SA
Contact
Status Withdrawn
Phase
Start date October 1, 2022
Completion date December 31, 2027
View Details
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