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

"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.

Study Overview

• Status: Recruiting
• Conditions: Left Main Coronary Artery Disease; Coronary Artery Disease (CAD); Chronic Coronary Syndrome; Coronary Bifurcation Lesion
• Intervention / Treatment: Procedure: IVUS-Guided LM PCI; Procedure: "Trained Eye" (Angiography-Guided) LM PCI

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aleksei A. Prokhorikhin, PhD; Phone Number: +79137178040; Email: aa.prohorihin@gmail.com

Study Locations

• Russia
  • Saint Petersburg, Russia
    • Recruiting
    • Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
    • Contact: Alexandra O. Conradi, M.D., Ph.D.; Phone Number: +79219931159; Email: konradi@almazovcentre.ru
    • Contact: Aleksei A. Prokhorikhin, M.D., Ph.D.; Phone Number: +79137178040; Email: aa.prohorihin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IVUS-Guided Approach; Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent.	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
Experimental: "Trained Eye" (Angiography-Guided) Approach; Stent sizing and procedural optimization guided by angiographic visual assessment and operator experience, with only IVUS assessment after intervention.	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 assess planimetric result (not used to guide the procedure itself)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative optimal LM stent expansion	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	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)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All individual components of DoCE at all time points.	Proportion of patients (%) achieving individual components of DoCE.	1 year follow-up

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; Bifurcation; Intravascular ultrasound; Left main; IVUS-trained eye; Stent optimization; Minimal stent area
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: EYE-IVUS LM Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Demographic, clinical, procedural and follow-up data. No personal data will be shared
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No