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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Device: Impella CP

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rayyan Hemetsberger, MD; Phone Number: 0043 1 40400 46140; Email: rayyan.hemetsberger@meduniwien.ac.at
• Study Contact Backup: Name: Kevin Hamzaraj, MD; Phone Number: 0043 1 40400 46 140; Email: kevin.hamzaraj@meduniwien.ac.at

Study Locations

• Austria
  • State of Vienna
    • Vienna, State of Vienna, Austria, 1090
      • Medical University of Vienna
      • Contact: Rayyan Hemetsberger, MD; Phone Number: 0043 1 40400 46140; Email: rayyan.hemetsberger@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Impella CP Auto-mode; 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.	Device: Impella CP; 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.
Active Comparator: Impella CP P-2 Mode; 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).	Device: Impella CP; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Proportion of participants who die from any cause within 30 days after the index protected high-risk PCI procedure.	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.	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.	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.	30 days

Collaborators and Investigators

• Sponsor: Rayyan Hemetsberger
• Investigators: Study Chair: Serdar Farhan, MD, Lennox Hill Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: May 2, 2026
• First Submitted That Met QC Criteria: May 10, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Mechanical Circulatory Support; Hemodynamic Support; Impella CP; Protected PCI; High-Risk PCI; STRATUS-PCI
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: STRATUS-PCI Pilot RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to the regulations in Austria and the DSGVO (law for data protection)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes