STRATegy SUccesS in High-Risk PCI With Impella CP: Evaluation of Hemodynamic Protection in Complex PCI
Starting soon · Not applicable
Conditions studied: Coronary Artery Disease, Heart Failure With Reduced Ejection Fraction
In brief
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.
Key facts
- Study ID
- NCT07588399
- Run by
- Rayyan Hemetsberger
- People needed
- 50
- Starts
- 2026-07-01
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2026-05-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- signed written informed consent
- age ≥ 18 years
- presentation in chronic coronary syndrome or acute coronary syndrome (STEMI ≥ 24h)
- LV-EF ≤ 40 % and one of the following parameters:
- Last remaining artery Unprotected LM-PCI + severe RCA stenosis or CTO Unprotected LM-PCI + left dominance Unprotected LM-PCI + severe aortic stenosis Unprotected LM-PCI + severe mitral regurgitation RCA PCI + unprotected severe LM stenosis RCA PCI + proximal LAD stenosis + proximal LCx stenosis
You may not qualify if…
- no written informed consent
- pregnancy
- acute infection
- recent ST-elevation myocardial infarction (< 24 hours) or not normalized CK-MB enzymes
Where it is running
- Medical University of Vienna — Vienna, State of Vienna, Austria
Full record on ClinicalTrials.gov
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