4
Participants
Start Date
October 28, 2023
Primary Completion Date
May 10, 2024
Study Completion Date
December 6, 2024
Impella CP®
"Subjects randomized to the Treatment Arm will undergo Impella CP placement prior to PCI. Right heart catheterization will be performed prior to or immediately after PCI.~Use of IABP will not be allowed in the Treatment Arm."
Standard of Care
This may include inotropes and/or vasopressors. An IABP may or may not be used according to local practice and the specific condition of each individual patient. If an IABP is used, it may be placed prior to or after PCI, and its timing of explant is left to the discretion of the Investigator.
New Mexico Heart Institute, Albuquerque
Rigshospitalet Copenhagen, Copenhagen
University Hospital Düsseldorf, Düsseldorf
Universitatsklinikum Schleswig Holstein, Kiel
Krankenhaus der Barmherzigen Brüder Trier, Trier
Inselspital Bern, Bern
Herzzentrum Dresden, Dresden
Lead Sponsor
Abiomed Inc.
INDUSTRY