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

NCT07711106 | Recruiting

• 1 other identifier: EYE-IVUS LM Trial
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease (CAD); Chronic Coronary Syndrome; Left Main Coronary Artery Disease; Coronary Bifurcation Lesion

Keywords

Intravascular ultrasound; Percutaneous coronary intervention; Left main; Bifurcation; IVUS-trained eye; Stent optimization; Minimal stent area

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• All individual components of DoCE at all time points.

  1 year follow-up

Study Arms (2)

IVUS-Guided Approach

ACTIVE COMPARATOR

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

"Trained Eye" (Angiography-Guided) Approach

EXPERIMENTAL

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

Interventions

IVUS-Guided LM PCI PROCEDURE

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

IVUS-Guided Approach

"Trained Eye" (Angiography-Guided) LM PCI PROCEDURE

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)

"Trained Eye" (Angiography-Guided) Approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Saint Petersburg, Russia

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Aleksei A. Prokhorikhin, PhD

CONTACT

+79137178040; aa.prohorihin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director for Science

Model Details: Web-based randomization platform (Sealed Envelope), performed after eligibility confirmation and informed consent

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 17, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

RU (1)