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"Expert IVUS-Eye" vs. IVUS-guided Left Main Bifurcation PCI (EYE-IVUS LM)

14. juli 2026 oppdatert av: Conrady Alexandra, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

"IVUS-Trained Eye" vs. Intravascular Ultrasound in Left Main Bifurcation Stenting: A Prospective Randomized Trial

This is a prospective, randomized, controlled trial comparing two strategies for optimizing stent implantation during bifurcation stenting of the left main coronary artery (LM): an intravascular ultrasound (IVUS)-guided approach versus a "IVUS-trained eye" approach based on angiographic assessment and operator experience. All patients receive the same stent brand and procedure steps to minimize variability. The primary objective is to compare the planimetric stent appearance between two strategies.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Stenting of the left main coronary artery in bifurcation lesions remains one of the most technically demanding tasks in interventional cardiology. Stent implantation quality is directly linked to the risk of adverse outcomes. Minimal stent area (MSA), as measured by IVUS, is a key predictor of adverse clinical outcomes. In practice, however, many centers continue to rely on angiographic assessment alone when performing various left main bifurcation stenting techniques. Proponents of this approach cite extensive clinical experience, anatomical familiarity, and IVUS-informed intuition developed over time (a "trained eye"). To date, no randomized data exist comparing outcomes of left main stenting between an IVUS-guided approach and a visually/experience-guided approach. Investigators hypothesize that, when combined with mandatory bifurcation optimization steps (e.g., proximal optimization technique [POT], kissing balloon inflation [KBI]), an angiography-only approach performed by an IVUS-experienced physician is non-inferior to a standard IVUS-guided approach, as assessed by post-PCI IVUS stent planimetric characteristics.

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

Studiesteder

  • Russland
      • Saint Petersburg, Russland
        • Rekruttering
        • Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
        • Ta kontakt med:
        • Ta kontakt med:

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:

  • De novo lesion in an unprotected left main coronary artery, indicated for bifurcational stenting (provisional or 2-stent)
  • Patient referred for elective or delayed (non-emergency) stenting
  • Technical feasibility of performing IVUS
  • Signed informed consent

Exclusion Criteria:

  • ST-elevation myocardial infarction (STEMI) within the preceding 72 hours
  • Cardiogenic shock
  • Isolated (non-bifurcation) left main lesion
  • Prior PCI in the target segment
  • Diameter of one of the left main main branches < 2 mm
  • Occlusion in the proximal segment of one of the main left main branches without the possibility of simultaneous recanalization
  • History of coronary artery bypass grafting (CABG)
  • Severe comorbidity with expected life expectancy < 1 year
  • Participation in another interventional study
  • Patient is a woman who is pregnant or nursing;
  • Female patient of childbearing potential, i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause);
  • IVUS is strictly required for pre-PCI lesion severity assessment
  • Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 6 months in stable patients and 1 year in ACS patients;
  • Known contraindication or hypersensitivity to everolimus, platinum-chromium, or to anticoagulants.

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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: IVUS-Guided Approach
Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent.
Fremgangsmåte: IVUS-Guided LM PCI

Coronary stent - single manufacturer and model ("Calypso", R-Vascular, Russia) used in all patients, to minimize variability related to stent design (strut thickness, cell design, expansion limits).

Procedure steps:

  • Baseline IVUS pullback - assessment of proximal and distal reference segments and lesion length
  • Stent selection based on IVUS data
  • Stent implantation
  • Mandatory optimization: kissing balloon dilation; proximal optimization
  • Final IVUS pullback to confirm result
Eksperimentell: "Trained Eye" (Angiography-Guided) Approach
Stent sizing and procedural optimization guided by angiographic visual assessment and operator experience, with only IVUS assessment after intervention.
Fremgangsmåte: "Trained Eye" (Angiography-Guided) LM PCI

Coronary stent - single manufacturer and model ("Calypso", R-Vascular, Russia) used in all patients, to minimize variability related to stent design (strut thickness, cell design, expansion limits).

Procedure steps:

  • Anatomical assessment based on visual angiographic evaluation
  • Stent and balloon selection at operator discretion
  • Stent implantation
  • Mandatory optimization (same steps: kissing balloon dilation, proximal optimization)
  • Final IVUS pullback performed only afterward, solely to assess planimetric result (not used to guide the procedure itself)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Relative optimal LM stent expansion
Tidsramme: Immediately post-procedure
Proportion of patients (%) achieving MSA ≥ 90% of the distal reference segment area according to IVUS, assessed after completion of all stenting and optimization steps
Immediately post-procedure
Absolute optimal LM stent expansion
Tidsramme: Immediately post-procedure
Proportion of patients (%) achieving MSA ≥ 11.4 mm² in the left main coronary artery according to IVUS, assessed after completion of all stenting and optimization steps
Immediately post-procedure
Device-oriented Composite Endpoint (DoCE)
Tidsramme: 1 year follow-up
Proportion of patients (%), achieving the device-oriented Composite Endpoint (DoCE) defined as the composite of: Cardiovascular death, target vessel MI, clinically indicated repeat revascularization of the target lesion at longest follow-up
1 year follow-up

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
All individual components of DoCE at all time points.
Tidsramme: 1 year follow-up
Proportion of patients (%) achieving individual components of DoCE.
1 year follow-up

Samarbeidspartnere og etterforskere

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

Sponsor

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

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 (Faktiske)

1. juli 2026

Primær fullføring (Antatt)

1. januar 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

7. juli 2026

Først innsendt som oppfylte QC-kriteriene

14. juli 2026

Først lagt ut (Faktiske)

17. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EYE-IVUS LM Trial

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Demographic, clinical, procedural and follow-up data. No personal data will be shared

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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