Comparing two Impella CP pump settings during high-risk heart artery opening procedures
Compares two pump settings during artery-opening procedures in people with weakened heart muscle.
Plain-language title generated from the registry record
Registry title: STRATegy SUccesS in High-Risk PCI With Impella CP: Evaluation of Hemodynamic Protection in Complex PCI
Key facts
- Where
- Vienna, AustriaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with weak heart pumping (LV-EF 40 % or lower) who need a high-risk procedure to open blocked heart arteries with a small heart pump called Impella CP.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Chronic or acute coronary syndrome (heart attack at least 24 hours ago), with LV-EF 40 % or lower and a high-risk pattern of blocked arteries, such as the last remaining artery or an unprotected left main artery narrowing combined with other severe heart problems
Main reasons for not taking part
- No signed written informed consent
- Pregnancy
- Acute infection
- Heart attack (ST-elevation) less than 24 hours ago
- CK-MB enzymes not yet back to normal
Read by machine on 9 November 2026.
Where in Austria
- Medical University of ViennaVienna, AustriaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Rayyan Hemetsberger
- Trial code
- NCT07588399
- Record updated
- 27 May 2026
- Original description
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.Read full original descriptionShow less
Randomized Pilot Study to Mechanistically Evaluate Automatic Flow Mode on Impella CP Device During Protected Complex Percutaneous Coronary Intervention
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.
Inclusion: 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.
Exclusion: acute infection; recent ST-elevation myocardial infarction (< 24 hours) or not normalized CK-MB enzymes; no written informed consent; pregnancy.