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

22. mai 2026 oppdatert av: Rayyan Hemetsberger

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.
Aktiv komparator: 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).
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Strategy Success
Tidsramme: 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.
48 hours

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
All-cause mortality
Tidsramme: 30 days
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)
Tidsramme: 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.
30 days
Target vessel myocardial infarction (TV-MI)
Tidsramme: 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.
30 days
Early stent thrombosis
Tidsramme: 30 days
Proportion of participants with definite or probable stent thrombosis (per Academic Research Consortium criteria) within 30 days after the index procedure.
30 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Rayyan Hemetsberger

Etterforskere

  • Studiestol: Serdar Farhan, MD, Lennox Hill Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. juli 2027

Studiet fullført (Antatt)

1. oktober 2027

Datoer for studieregistrering

Først innsendt

2. mai 2026

Først innsendt som oppfylte QC-kriteriene

10. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STRATUS-PCI Pilot RCT

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

According to the regulations in Austria and the DSGVO (law for data protection)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

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