Clinical Research Directory
Browse clinical research sites, groups, and studies.
STRATegy SUccesS in High-Risk PCI With Impella CP: Evaluation of Hemodynamic Protection in Complex PCI
Sponsor: Rayyan Hemetsberger
Summary
STRATUS-PCI is a pilot clinical trial that compares two ways of running a small heart pump called Impella CP during a high-risk procedure to open blocked heart arteries (percutaneous coronary intervention, or PCI) in patients with weakened heart muscle. The pump is placed temporarily through an artery in the leg and sits across the aortic valve to help maintain blood flow during the procedure. Fifty patients will be randomly assigned in equal numbers to one of two pump settings: an automatic mode that adjusts flow up to higher levels as needed, or a fixed lower-flow mode (P-2). The doctor performing the heart procedure will not know which setting is being used (double-blind). A separate doctor monitors blood pressure and is allowed to change the pump setting at any time if the patient becomes unstable. The main question is whether the automatic mode helps doctors complete the planned heart procedure more successfully and without drops in blood pressure or other complications. Results will help design a larger future trial.
Official title: Randomized Pilot Study to Mechanistically Evaluate Automatic Flow Mode on Impella CP Device During Protected Complex Percutaneous Coronary Intervention
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-07-01
Completion Date
2027-10-01
Last Updated
2026-05-27
Healthy Volunteers
No
Interventions
Impella CP
The Impella CP is a transvalvular axial-flow micro-pump for temporary mechanical circulatory support, inserted via a 14F sheath into the femoral artery and positioned across the aortic valve. The pump draws blood from the left ventricle and delivers it to the ascending aorta, providing forward flow up to approximately 4.3 L/min while reducing left ventricular work and end-diastolic pressure. In this study, the device is used in all participants undergoing protected high-risk PCI, with the operating modality (Auto-mode in the experimental arm vs. fixed P-2 mode in the active comparator arm) determined by 1:1 randomization. The unblinded study investigator may escalate Impella support if predefined hemodynamic instability criteria are met.
Locations (1)
Medical University of Vienna
Vienna, State of Vienna, Austria