Coronary Artery DiseaseSTRATUS-PCINCT07588399
STRATegy SUccesS in High-Risk PCI With Impella CP: Evaluation of Hemodynamic Protection in Complex PCI
A study testing Impella CP in people with Coronary Artery Disease and Heart Failure With Reduced Ejection Fraction, run by Rayyan Hemetsberger at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Impella CP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jul 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- no written informed consent
- pregnancy
- acute infection
- recent ST-elevation myocardial infarction (< 24 hours) or not normalized CK-MB enzymes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Medical University of Vienna
Vienna, State of Vienna, 1090
Rayyan Hemetsberger, MD, 0043 1 40400 46140, rayyan.hemetsberger@meduniwien.ac.at
About this study
Official title: 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.
Read the detailed description
STRATUS-PCI is an investigator-initiated, double-blind, randomized controlled pilot study evaluating two operating modalities of the Impella CP transvalvular axial-flow pump in patients undergoing protected complex high-risk percutaneous coronary intervention (PCI). Eligible participants are randomized 1:1 to either Impella CP Auto-mode (experimental) or Impella CP P-2 mode (active comparator, 1.3-2.1 L/min).
- Being tested
- Impella CP
- Keywords
- Impella CP, Mechanical Circulatory Support, Protected PCI, High-Risk PCI, Hemodynamic Support, STRATUS-PCI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impella CPDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Impella CP Auto-mode | Experimental | Patients in this arm receive temporary mechanical circulatory support with the Impella CP transvalvular axial-flow pump operating in Auto-mode (SmartAssist) throughout the protected high-risk percutaneous coronary intervention. In Auto-mode, pump speed (P-level) is automatically adjusted in real time based on hemodynamic feedback, with maximum flow up to approximately 4.3 L/min. Receives: Device: Impella CP |
| Impella CP P-2 Mode | Active comparator | Patients in this arm receive temporary mechanical circulatory support with the Impella CP transvalvular axial-flow pump operating in the fixed P-2 setting (approximately 1.3-2.1 L/min flow) at the start of the procedure. The unblinded study investigator continuously monitors hemodynamics during the procedure and is empowered to escalate Impella support to a higher P-level (or Auto-mode) without operator confirmation if any predefined hemodynamic instability criterion is met (MAP drop ≥ 25 mmHg, MAP < 60 mmHg for > 1 minute, flat line, catecholamine need, periprocedural resuscitation, or ventilation). Receives: Device: Impella CP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strategy Success
The primary endpoint is strategy success, defined as completing the procedure with successful uncomplicated PCI of all intended segments with a TIMI flow of 3 and residual stenosis of less than 30% without hemodynamic instability. Hemodynamic instability in our study is defined as 25 mmHg (as defined in past randomized studies) decrease on baseline mean arterial pressure (MAP) for longer than 1 minute or MAP of under 60 mmHg for longer than 1 minute, flat line, administration of any dose of catecholamines, change on Impella CP modality, periprocedural resuscitation and/or ventilation. Complications are defined as periprocedural resuscitation, emergency surgery, periprocedural ventilation, death, periprocedural myocardial infarction type 4a based on the 4th universal definition of myocardial infarction (35), periprocedural acute renal injury based on the 2012 KDIGO definition of acute kidney injury (36), bleeding BARC type 3 or 5.
Measured: 48 hours
Secondary outcomes (4)
All-cause mortality
Proportion of participants who die from any cause within 30 days after the index protected high-risk PCI procedure.
Measured: 30 days
Target lesion revascularization (TLR)
Proportion of participants undergoing any clinically driven repeat revascularization (PCI or CABG) of the target lesion within 30 days after the index procedure.
Measured: 30 days
Target vessel myocardial infarction (TV-MI)
Proportion of participants with myocardial infarction attributable to the target vessel within 30 days after the index procedure, defined per the 4th Universal Definition of Myocardial Infarction.
Measured: 30 days
Early stent thrombosis
Proportion of participants with definite or probable stent thrombosis (per Academic Research Consortium criteria) within 30 days after the index procedure.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rayyan Hemetsberger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rayyan Hemetsberger, Medical University of Vienna
- Investigators
- Serdar Farhan, MD, Study chair, Lennox Hill Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588399
- Sponsor's protocol ID
- STRATUS-PCI Pilot RCT
- Acronym
- STRATUS-PCI
- Status last verified
- May 2026
- First submitted
- 2 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: According to the regulations in Austria and the DSGVO (law for data protection)
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Study to Mechanistically Evaluate Automatic Flow Mode on Impella CP Device During Protected Complex Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT07588399
- Acronym / sponsor ID
- STRATUS-PCI / STRATUS-PCI Pilot RCT
- Keywords
- Impella CP, Mechanical Circulatory Support, Protected PCI, High-Risk PCI, Hemodynamic Support, STRATUS-PCI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rayyan HemetsbergerUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
STRATUS-PCI is an investigator-initiated, double-blind, randomized controlled pilot study evaluating two operating modalities of the Impella CP transvalvular axial-flow pump in patients undergoing protected complex high-risk percutaneous coronary intervention (PCI). Eligible participants are randomized 1:1 to either Impella CP Auto-mode (experimental) or Impella CP P-2 mode (active comparator, 1.3-2.1 L/min).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Impella CP Auto-mode | Experimental | Device: Impella CPPatients in this arm receive temporary mechanical circulatory support with the Impella CP transvalvular axial-flow pump operating in Auto-mode (SmartAssist) throughout the protected high-risk percutaneous coronary intervention. In Auto-mode, pump speed (P-level) is automatically adjusted in real time based on hemodynamic feedback, with maximum flow up to approximately 4.3 L/min. |
| Impella CP P-2 Mode | Active comparator | Device: Impella CPPatients in this arm receive temporary mechanical circulatory support with the Impella CP transvalvular axial-flow pump operating in the fixed P-2 setting (approximately 1.3-2.1 L/min flow) at the start of the procedure. The unblinded study investigator continuously monitors hemodynamics during the procedure and is empowered to escalate Impella support to a higher P-level (or Auto-mode) without operator confirmation if any predefined hemodynamic instability criterion is met (MAP drop ≥ 25 mmHg, MAP < 60 mmHg for > 1 minute, flat line, catecholamine need, periprocedural resuscitation, or ventilation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- no written informed consent
- pregnancy
- acute infection
- recent ST-elevation myocardial infarction (< 24 hours) or not normalized CK-MB enzymes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impella CPThe 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. | Device | Impella CP Auto-mode, Impella CP P-2 Mode |
Primary outcome
Strategy Success
Time frame: 48 hours
The primary endpoint is strategy success, defined as completing the procedure with successful uncomplicated PCI of all intended segments with a TIMI flow of 3 and residual stenosis of less than 30% without hemodynamic instability. Hemodynamic instability in our study is defined as 25 mmHg (as defined in past randomized studies) decrease on baseline mean arterial pressure (MAP) for longer than 1 minute or MAP of under 60 mmHg for longer than 1 minute, flat line, administration of any dose of catecholamines, change on Impella CP modality, periprocedural resuscitation and/or ventilation. Complications are defined as periprocedural resuscitation, emergency surgery, periprocedural ventilation, death, periprocedural myocardial infarction type 4a based on the 4th universal definition of myocardial infarction (35), periprocedural acute renal injury based on the 2012 KDIGO definition of acute kidney injury (36), bleeding BARC type 3 or 5.
4 secondary outcomes
All-cause mortality
Time frame: 30 days
Target lesion revascularization (TLR)
Time frame: 30 days
Target vessel myocardial infarction (TV-MI)
Time frame: 30 days
Early stent thrombosis
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No. According to the regulations in Austria and the DSGVO (law for data protection)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Serdar Farhan, MD study chair
Lennox Hill Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impella CP in people with Coronary Artery Disease and Heart Failure With Reduced Ejection Fraction, run by Rayyan Hemetsberger at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rayyan Hemetsberger, MD (0043 1 40400 46140, rayyan.hemetsberger@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strategy Success (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.