STRATegy SUccesS in High-Risk PCI With Impella CP: Evaluation of Hemodynamic Protection in Comple… (NCT07588399) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
STRATegy SUccesS in High-Risk PCI With Impella CP: Evaluation of Hemodynamic Protection in Complex PCI
Austria50 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* no written informed consent
* pregnancy
* acute infection
* recent ST-elevation myocardial infarction (\< 24 hours) or not normalized CK-MB enzymes
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on 'strategy success' in high-risk PCI with an Impella CP device — can you explain what that actually means in practice, and whether my specific heart condition and ejection fraction would even make me a candidate to discuss this kind of approach?
2Since this trial isn't recruiting yet, how far away do you think enrollment might be, and should we be making treatment decisions now rather than waiting to see if I could potentially be considered for it later?
3The trial involves using the Impella CP, which is a mechanical heart pump placed during a complex PCI procedure — what are the real-world risks of having that device inserted on top of an already high-risk procedure, and how does that compare to doing the PCI without it?
4Because this is listed as Phase NA rather than a traditional Phase 1, 2, or 3 trial, what does that tell us about how much is already known about the safety and effectiveness of this Impella-supported PCI strategy?
5Are there standard-of-care options for high-risk PCI or for managing heart failure with reduced ejection fraction that I should be pursuing right now, rather than waiting for a trial that hasn't started enrolling yet?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.