A prospective, multicenter, single-arm, open label registry of commercially treated patients with PiCSO Impulse System.
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 Type
OBSERVATIONAL
Percutaneous coronary intervention
Herzzentrum Dresden GmbH Universitätsklinik an der TU Dresden
Dresden, Germany
Adverse Device Effect (ADE) rate at 30 days post index procedure PCI
Adverse Device Effect (ADE) rate at 30 days post index procedure PCI
Time frame: 30 days
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