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Not yet recruiting NCT07588399

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

No phase Interventional Coronary Artery Disease Heart Failure With Reduced Ejection Fraction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Impella CP.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Heart Failure With Reduced Ejection Fraction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Interventions

  • 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 operat

Primary outcome measures

  • Strategy Success [Time frame: 48 hours]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Austria · 1 center
  • Medical University of Vienna — Vienna

Identifiers

NCT: NCT07588399 · STRATUS-PCI Pilot RCT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗