Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07588399

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Heart Failure With Reduced Ejection Fraction Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. All-cause mortality

    Time frame: 30 days

    Proportion of participants who die from any cause within 30 days after the index protected high-risk PCI procedure.

  2. Target lesion revascularization (TLR)

    Time frame: 30 days

    Proportion of participants undergoing any clinically driven repeat revascularization (PCI or CABG) of the target lesion within 30 days after the index procedure.

  3. Target vessel myocardial infarction (TV-MI)

    Time frame: 30 days

    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.

  4. Early stent thrombosis

    Time frame: 30 days

    Proportion of participants with definite or probable stent thrombosis (per Academic Research Consortium criteria) within 30 days after the index procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin Hamzaraj, MD

CONTACT

[email protected]

0043 1 40400 46 140

Rayyan Hemetsberger, MD

CONTACT

[email protected]

0043 1 40400 46140

Sponsors and collaborators

Lead sponsor

Rayyan Hemetsberger

Other

Registry information

Official study title

Randomized Pilot Study to Mechanistically Evaluate Automatic Flow Mode on Impella CP Device During Protected Complex Percutaneous Coronary Intervention

Acronym: STRATUS-PCI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 14, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.