"Expert IVUS-Eye" vs. IVUS-guided Left Main Bifurcation PCI

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Procedure 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
• Procedure "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

Primary outcome measures

• Relative optimal LM stent expansion [Time frame: Immediately post-procedure]
• Absolute optimal LM stent expansion [Time frame: Immediately post-procedure]
• Device-oriented Composite Endpoint (DoCE) [Time frame: 1 year follow-up]

Secondary outcome measures (1)

• All individual components of DoCE at all time points. [Time frame: 1 year follow-up]

Eligibility criteria

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.

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

Open label

Primary purpose

Treatment

Study locations

Russia · 1 center

• Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Cen — Saint Petersburg

Identifiers

NCT: NCT07711106 · EYE-IVUS LM Trial

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗