STRATegy SUccesS in High-Risk PCI With Impella CP: Evaluation of Hemodynamic Protection in Complex PCI

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.

NCT Number	NCT07588399
Lead Sponsor	Rayyan Hemetsberger
Conditions	Coronary Artery Disease, Heart Failure With Reduced Ejection Fraction
Enrollment	50 participants
Start Date	2026-07-01
Primary Completion	2027-07-01 (estimated)
Study Completion	2027-10-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-27