RecruitingNot ApplicableNCT07711106

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

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

Sponsor

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

Enrollment

50 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called "Trained Eye" (Angiography-Guided) LM PCI and a procedure called IVUS-Guided LM PCI for people with chronic coronary syndrome, coronary artery disease (cad), and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIVUS-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 assess planimetric result (not used to guide the procedure itself)

Locations(1)

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

Saint Petersburg, Russia

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NCT07711106

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