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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Herzzentrum Dresden GmbH Universitätsklinik an der TU Dresden
Dresden, Germany
Start Date
October 1, 2022
Primary Completion Date
December 31, 2024
Completion Date
December 31, 2027
Last Updated
March 8, 2023
PiCSO
DEVICE
Lead Sponsor
Miracor Medical SA
NCT06438315
NCT07160491
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06678074