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

NCT07588399 | Not Yet Recruiting FDA Device

• 1 other identifier: STRATUS-PCI Pilot RCT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Heart Failure With Reduced Ejection Fraction

Keywords

Impella CP; Mechanical Circulatory Support; Protected PCI; High-Risk PCI; Hemodynamic Support; STRATUS-PCI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• All-cause mortality

  30 days

• Target lesion revascularization (TLR)

  30 days

• Target vessel myocardial infarction (TV-MI)

  30 days

• Early stent thrombosis

  30 days

Study Arms (2)

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.

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).

Device: Impella CP

Interventions

Impella CP DEVICE

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.

Impella CP Auto-mode; Impella CP P-2 Mode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Rayyan Hemetsberger: lead

Study Sites (1)

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Serdar Farhan, MD

  Lennox Hill Hospital

  STUDY CHAIR

Central Study Contacts

Rayyan Hemetsberger, MD

CONTACT

0043 1 40400 46140; rayyan.hemetsberger@meduniwien.ac.at

Kevin Hamzaraj, MD

CONTACT

0043 1 40400 46 140; kevin.hamzaraj@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Heart Catheterization Laboratory

Study Record Dates

• First Submitted: May 2, 2026
• First Posted: May 14, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)