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RECRUITING
NCT07711106
NA

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

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

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-07-01

Completion Date

2027-12-31

Last Updated

2026-07-17

Healthy Volunteers

No

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 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